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More than a Quality Management System: Tools for the entire MedTech Lifecycle.

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Featured Capabilities:

Document Management Training Management Product Development Design Control Risk Management CAPA Management Audit Management

Experience the #1 QMS software for medical device companies first-hand. Click through an interactive demo.

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Data collection and management designed for MedTech clinical trials.

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Featured Capabilities:

Electronic Data Capture (EDC) Electronic Case Report Forms (eCRF) Electronic Patient Reported Outcomes (ePRO) Ad-Hoc Data Collection (Cases) Post-Market Surveys Product Add-Ons

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Ultimate Guide to Comparing Quality Management System Solutions

This eBook compares the best QMS software solutions to help medical device companies make an informed decision when investing in a quality management system.

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Explore Our Resources

Helping you imagine, introduce, and advance better medical technologies.
Featured eBook

AI in MedTech Trend Report 2023

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eBook

Best QMS Software: Ultimate Guide To Comparing Quality Management System Solutions

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eBook

Ultimate Guide to ISO 14155:2020 for Medical Devices

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Webinar

Global UDI Updates: Navigating EUDAMED Changes & Health Authority Trends

Informative webinar providing updates on medical device UDI activity worldwide, including the latest legislations impacting EUDAMED, current status on Australia AusUDID and other ...

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Global Medical Device Podcast

Clinical Evidence: The Key to Market Adoption

Episode 374

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Checklists and Templates

Complaint Form Template

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Global Medical Device Podcast

Creative Clinical Recruitment

Episode 373

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Global Medical Device Podcast

Getting Hired In MedTech

Episode 372

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Global Medical Device Podcast

Achieving ISO 13485 Certification

Episode 371

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Webinar

From LDTs to IVDs: Navigating the New Regulatory Landscape

Insightful webinar covering the evolution and current state of Laboratory Developed Tests (LDTs), and how to navigate the new regulatory landscape.

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Checklists and Templates

How to Clear a Software Medical Device

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Webinar

Strategies for Navigating the EU MDR Extension Deadlines

This webinar will explore the complexities of the Medical Device Regulation (MDR) journey by deep diving into its multifaceted challenges and emphasizing the pivotal year of 2024 ...

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Checklists and Templates

FDA Pre-Submission Meeting Checklist

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Global Medical Device Podcast

Meet a Guru: Jamie Bihary

Episode 370

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Global Medical Device Podcast

Advice to Medical Device Inventors

Episode 369

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Global Medical Device Podcast

Obtaining Institutional Review Board (IRB) Approval

Episode 368

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Global Medical Device Podcast

Interviewing the Interviewer

Episode 367

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Webinar

Enhancing Clinical Data Collection with Greenlight Guru Clinical's Add-ons

Join us for a 25-minute live demo showcasing Greenlight Guru Clinical’s powerful add-ons, designed to elevate your clinical data collection & management experience.

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Webinar

Conducting Effective FDA Pre-Sub Meetings: Best Practices to Avoid Timely & Costly Mistakes

Free webinar about pre-submission meetings with FDA, covering best practices to avoid timely and costly mistakes and creative ways to use the pre-sub program as a competitive ...

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eBook

Ultimate Guide to Clinical Data Management in MedTech

Comprehensive guide with best practices for managing clinical data in a compliant manner, as well as pitfalls to avoid, and the tools available to help you in your clinical ...

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Checklists and Templates

GSPR Template

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Checklists and Templates

Medical Devices Essential Principles Checklist

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Global Medical Device Podcast

Cardiac Arrest: 5 Heart-Stopping Years as a CEO on the Feds Hit-List

Episode 366

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Checklists and Templates

MDSAP QMS Audit Checklist

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Webinar

Decoding 'Sufficient Clinical Evidence' under EU MDR for Medical Devices

This webinar explores what 'sufficient clinical evidence' under EU MDR means for medical devices and offers insights to enable manufacturers to understand this requirement.

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Webinar

Enhancing Post-Market Activities with Greenlight Guru’s Quality Event Workflows

In-depth demonstration of our QMS software, showcasing quality event workflows and automations for creating scalable, repeatable processes.

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Global Medical Device Podcast

Medical Device Reporting: The Do's and Don'ts

Episode 365

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Global Medical Device Podcast

Building a Partnership with your Regulatory Consultant

Episode 364

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Checklists and Templates

Clinical Investigation Plan (CIP) Synopsis Template

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Global Medical Device Podcast

Bringing a Self-Funded Medical Device to Market

Episode 363

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Webinar

IEC 62366-1 Essentials: Elevating User Safety in Medical Devices

Insightful webinar providing the knowledge and tools you need to apply IEC 62366-1 effectively to make your devices safer and more user-friendly.

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Webinar

Mastering the Design Transfer Process

In-depth webinar providing best practices to ensure a successful design transfer process and proper documentation as well as detailed instructions and strategies to help you ...

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Global Medical Device Podcast

Managing Risk in Clinical Investigations

Episode 362

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Global Medical Device Podcast

Speaking the Language of IVD

Episode 361

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Checklists and Templates

Resource Bundle for Risk Managers

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Checklists and Templates

FDA QSR, QMSR & ISO 13485:2016 Internal Audit Checklist

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Global Medical Device Podcast

Is It Possible to "Buy" a QMS?

Episode 360

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Global Medical Device Podcast

Project Management in MedTech

Episode 359

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Webinar

Designing Effective PMCF Surveys in Greenlight Guru Clinical

Join this live demonstration on how to create effective PMCF surveys in Greenlight Guru Clinical, the leading software for MedTech clinical data collection.

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Webinar

Revolutionizing Medical Device Trials with Risk-Based Monitoring

Join this webinar to learn how Risk-Based Monitoring not only meets the unique challenges of medical device trials but also enhances patient safety, data integrity, and ...

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Webinar

Mastering Document and Change Management with Greenlight Guru Quality

In-depth live demonstration of our document management and change management workflows in Greenlight Guru's QMS software, designed specifically for MedTech companies.

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Checklists and Templates

Premarket Approval Inspection Checklist

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Webinar

Live Q&A with FDA: Cybersecurity Premarket Guidance

Interactive webinar with FDA members answering audience questions and providing new insights on the pre-market guidance for cybersecurity in medical devices.

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Events

True Quality Roadshow 2024

Join us for free, in person at a True Quality Roadshow event! Coming to Boston, Copenhagen, Austin, & Salt Lake City

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Events

2024 State of the MedTech Industry True Quality Summit Series

In an industry where non-compliance can cost millions and lead to poor patient outcomes, staying ahead of these regulations is imperative. To help navigate these complexities, ...

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Global Medical Device Podcast

FDA's Voluntary Improvement Program

Episode 358

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Global Medical Device Podcast

The State of UDI Across the World

Episode 357

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Webinar

Key Expectations for ISO 14971 Compliance with Implementation of QMSR

Free webinar exploring ISO 14971 and QMSR to help medical device professionals learn how to adapt risk management processes to meet new regulations and implement a risk-focused ...

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eBook

Guide to Managing Your Medical Device on the Market and Scaling Manufacturing

Comprehensive guide for established MedTech companies covering the many facets of managing a medical device after market entry and best practices to follow.

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Webinar

Insights from TÜV SÜD and Greenlight Guru on the Requirements of PMCF under the MDR 2017/745

In this webinar, experts from TÜV SÜD and Greenlight Guru will explore examples of PMCF methods. Sign up to get a better understanding of PMCF.

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Webinar

Leveraging Automated Training with Greenlight Guru Quality

This live demo offers a look into how our Training Management software, specifically new functionality enhancements to simplify training administration tasks that significantly ...

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Webinar

QMSR Final Rule: Meeting FDA’s New Requirements

This webinar provides an in-depth overview of the QMSR final rule, how FDA responsed to the proposed rule comments, and how it may impact the MedTech industry and FDA. Particular ...

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Webinar

eSTAR 5.0: Are You Ready?

Free, in-depth webinar to guide you through the intricacies of the latest eSTAR 5.0 platform, crucial for any medical device manufacturer planning a 510(k), De Novo, or PMA ...

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Global Medical Device Podcast

Quality Myths & Lessons Learned Part II

Episode 356

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Checklists and Templates

Cybersecurity Gap Assessment Checklist

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Global Medical Device Podcast

Mastering the Pitch: MedTech Innovations from Concept to Market

Episode 355

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Global Medical Device Podcast

Becoming a MedTech Regulatory Affairs Professional

Episode 354

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Webinar

Significant Risk vs. Nonsignificant Risk Devices: What’s the Difference & Why Does It Matter?

Register for this webinar to learn about significant risk vs. nonsignificant risk, including best practices to avoid timely, costly mistakes and creative ways to use the SR and ...

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Checklists and Templates

FDA QMSR & ISO 13485:2016 QMS Internal Audit Checklist

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Global Medical Device Podcast

How Artificial Intelligence is Impacting the MedTech Industry

Episode 353

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Webinar

Streamline Your Clinical Data Management with Greenlight Guru Clinical's Reporting Module

This live demo session will showcase the new Reporting module from Greenlight Guru Clinical, emphasizing its role in streamlining clinical data management for the MedTech ...

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Webinar

Integrating Risk Management Throughout the Entire Device Lifecycle with Greenlight Guru Quality

Live demo showing how our Risk Management software aligns with ISO 14971:2019, ensuring compliance and fostering collaboration for enhanced product safety, accelerated ...

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Global Medical Device Podcast

Fundamentals of Quality & Regulatory

Episode 352

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Webinar

Key Elements to Outsourcing Clinical Activities in 2024

Join us for this enlightening webinar where we will delve into critical insights and strategies essential for MedTech professionals involved in outsourcing or insourcing clinical ...

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Webinar

Integrating eCRF and ePRO in One Single Platform

In this live demo session, gain insights into Greenlight Guru Clinical's fully optimized functionality for a diverse range of clinical studies and RCTs.

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Global Medical Device Podcast

The State of AI & Clinical Investigations

Episode 351

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Global Medical Device Podcast

The Evolving Landscape of AI in MedTech

Episode 350

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Checklists and Templates

Align Your Clinical Claims Webinar Q&A

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Webinar

Achieving Real-Time Audit Readiness Using Greenlight Guru Quality

Live demonstration of how to conduct audits with ease and achieve real-time readiness using Greenlight Guru Quality, the leading QMS software for MedTech.

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Case Study

Swiss Medical Device Company Improves Clinical Data Collection and Management with Greenlight Guru Clinical

In need of an EDC solution that was easy to use and would improve the reliability and accuracy of their clinical data, this Swiss manufacturer turned to Greenlight Guru Clinical.

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Webinar

Demystifying FDA’s Pre-Market Final Guidance

Free webinar presented by FDA covering key highlights and updates from the final pre-market guidance to help MedTech companies prepare for the requirements.

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Global Medical Device Podcast

Climbing the MedTech Career Ladder - How to Get to the Top

Episode 349

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Global Medical Device Podcast

Considerations for IVD

Episode 348

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Global Medical Device Podcast

Human-Centered Design in Medical Devices

Episode 347

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eBook

Electronic Data Capture (EDC) Buyer’s Guide: Making the Business Case for a New EDC System

Whether you’ve got a new clinical trial on the horizon, or you’re just fed up with the limitations of the way you’re currently capturing clinical data, you’ve probably got a new ...

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Case Study

InnoCon Medical Chooses Greenlight Guru Clinical for a Modern, Streamlined EDC Solution

InnoCon Medical needed an electronic data capture (EDC) system, so they turned to Greenlight Guru Clinical for a simple, yet powerful clinical data solution.

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Webinar

Streamlining Your Medical Device Development with Greenlight Guru QMS: Live Demo

Live demo of Greenlight Guru Quality showing how to drive efficient, risk-based product development and quality management while simultaneously driving traceability throughout the ...

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Webinar

Maximizing Clinician Participation in Post-Market Operations

Live demo addressing key challenges faced by clinicians and distributors in obtaining post-market surveillance feedbac, and exploring best practices for successful clinician ...

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Global Medical Device Podcast

FDA's eSTAR Program

Episode 346

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Case Study

Smarter Renal Care Trials with Greenlight Guru Clinical

Quanta was looking for a flexible, integrable, and easy-to-use solution for their clinical studies, and chose Greenlight Guru Clinical (formerly SMART-TRIAL).

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Case Study

Brain Healthcare Innovator Firefly Neuroscience Uses Greenlight Guru Clinical

Firefly Neuroscience sought a solution that was equipped to cover the different types of studies they needed to perform, and found the perfect partner in Greenlight Guru Clinical

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Checklists and Templates

ChatGPT Sample Prompts for Risk Evaluation of a Medical Device

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Webinar

Mastering Medical Device Audits: A Proven Formula

This free webinar provides the tools and knowledge you need to master your next medical device audit, including specific areas to focus on during the audit preparation, how to ...

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Webinar

How to Estimate Sample Size for Medical Device Clinical Studies

To pass scrutiny from Notified Bodies on PMCF and clinical investigation plans, you have to justify sample size estimation with scientific reasoning. Watch this webinar to learn ...

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Webinar

Best Practices for Structuring Clinical Data in Medical Device Studies

How do you ensure that clinical data is collected in line with your study goals while taking the clinical workflow at the study sites into account? Watch this webinar, to find ...

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Case Study

How Medartis Found the Perfect Match for its Research Partners with Greenlight Guru Clinical

Medartis wanted to begin offering clinical research partners an electronic data capture (EDC) solution that would eliminate the use of spreadsheets—and turned to Greenlight Guru ...

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Global Medical Device Podcast

Using AI in MedTech

Episode 345

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Global Medical Device Podcast

Becoming an Advisor to a Medical Device Company

Episode 344

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Global Medical Device Podcast

Recent FDA Draft Guidances

Episode 343

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Webinar

Best Practices for Patient Recruitment in MedTech Clinical Studies

Subject recruitment in clinical studies is one of - if not the biggest - cause for delay in clinical study timelines. In this webinar, you will learn some of the best practices to ...

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Case Study

Sidekick Health Leverages Greenlight Guru Clinical for Research into Digital Health Products

With several clinical studies planned, Sidekick Health needed a modern electronic data capture (EDC) solution to help determine the effectiveness of their digital health products.

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Webinar

How Quality & Regulatory Compliance Drive Financial Performance in MedTech

Learn how to leverage quality and compliance for better financial outcomes in the MedTech sector in this webinar.

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eBook

AI in MedTech Trend Report 2023

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Case Study

Monarch Medical Makes Sense of Document Management With Greenlight Guru Quality

Monarch Medical chose Greenlight Guru for its MedTech-specific eQMS and unparalleled industry knowledge and customer service.

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Global Medical Device Podcast

Planning an FDA Submission

Episode 342

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Webinar

Upgrading Your QMS Solution: Practical Tips & Tricks for a Seamless Transition

Free webinar designed to guide medical device companies through the process of upgrading their Quality Management System (QMS) efficiently.

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Webinar

How to Boost Patient Recruitment in Greenlight Guru Clinical

In this session we will examine some of the common study recruitment models and how each model enables sponsors to maximize recruitment efficiencies. We will also take a look at ...

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Case Study

Loop Medical Switched from Paper and Got Real-Time Access to Data with Greenlight Guru Clinical

Tired of the inefficiency and lack of visibility with their paper system, Loop Medical turned to Greenlight Guru Clinical’s electronic data capture system and never looked back.

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Case Study

PSA Flanders Uses Greenlight Guru Clinical and Gets Exceptionally High Response Rates to their Survey

Needing an easy and intuitive survey solution that participants could use on their own time, PSA Flanders turned to Greenlight Guru Clinical and their modern electronic data ...

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Global Medical Device Podcast

What NOT to say to FDA

Episode 341

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Webinar

Demonstrating Conformity to General Safety and Performance Requirements (GSPR) under MDR

This webinar will provide you with insights on how comply with the General Safety and Performance Requirements (GSPR) of the EU Medical Device Regulation (EU MDR)

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Webinar

Align Your Clinical Claims with the Clinical Investigation Performance and Safety Endpoints

During this webinar we will focus on how to collect relevant clinical data to support market claims in an analytical way and align you with authorities' expectations.

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Global Medical Device Podcast

Understanding LDTs & the FDA Proposed Ruling

Episode 340

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Global Medical Device Podcast

UDI and EUDAMED: Past, Present and Future State

Episode 339

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Webinar

eCRF Setup and Forms Building in Greenlight Guru Clinical

Live, guided demonstration of eCRFs in Greenlight Guru Clinical, the leading software for MedTech clinical data collection.

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Webinar

Complaint Handling: How to Avoid the #3 Most Cited Reason for 483 Observations

Actionable webinar to help participants learn best practices for complaint handling to avoid timely and costly mistakes as well as creative ways to advantageously manage ...

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Global Medical Device Podcast

Selecting a Site for Your Clinical Trial

Episode 338

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Global Medical Device Podcast

Moving MedTech Forward - The Past, Present & Future of Greenlight Guru

Episode 337

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Webinar

QSR to QMSR: The Rewrite of 21 CFR Part 820 & Key Considerations for FDA Compliance

Informative webinar where FDA regulatory expert Eric Henry provides an overview of the QMSR proposed rule, explains next steps in the rule-making and implementation process, and ...

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Webinar

Expert Panel: Data Management and Monitoring in MedTech Clinical Studies

This panel session offers a unique opportunity to delve into the nuances of monitoring and data management to learn how to navigate the challenges these crucial areas present. ...

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Case Study

HTD Health Chooses Greenlight Guru Quality for a Modern, SaMD-Friendly eQMS

HTD Health chose Greenlight Guru for its adaptability and built-in compliance, as well as Greenlight Guru’s unparalleled industry knowledge and customer service.

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Case Study

Bernafon’s Clinical Trial Data Management Journey from Excel to Greenlight Guru Clinical

Bernafon overcame all previous challenges with data management and have continued to use Greenlight Guru's EDC software for all clinical trials. They managed to reduce time spent ...

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Case Study

World Leader in Regenerating Damaged Human Tissues Uses Greenlight Guru Clinical

Kerecis achieved full data compliance in both the US and Europe and managed running trials during the COVID-19 pandemic that limited in-person travel.

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Case Study

MDR Compliant Prospective & Retrospective Clinical Studies

With Greenlight Guru Clinical, Nobel Biocare continues to run their post-market clinical studies in less time spent on data management and study setup all while maintaining MDR ...

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Case Study

European IVD Startup Gets Fast, Accurate Clinical Data with Greenlight Guru's EDC System

Obtaining critical clinical data is essential to the startup’s goal of getting their in vitro diagnostic device to market. Greenlight Guru's EDC solution was easy to set up, ...

Greenlight Guru Clinical
Case Study

Clinical Trials on AI-Assessed QTc Measurement Directly from Consumer Smartwatches

Cardiologs selected Greenlight Guru Clinical's eCRF (formerly SMART-TRIAL) with an external API add-on as the solution. This enabled them to run the studies in a single system ...

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Case Study

How a Partnership with Greenlight Guru Helped Rook Quality Systems Grow 5X In Two Years

“Not having your Design control or Risk Management can be a $20M hair cut on the valuation of your company. I’ve seen first hand a small company being courted by a bigger ...

Greenlight Guru Clinical
Global Medical Device Podcast

From Academia to FDA Clearance (True Quality Roadshow - Boston)

Episode 336

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Global Medical Device Podcast

Accelerating SaMD Development in a Compliant Agile Way

Episode 335

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Global Medical Device Podcast

MedTech Funding and Preparing for Due Diligence

Episode 334

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Case Study

How Creo Medical Streamlined Innovation and Development with Greenlight Guru's QMS Software

Creo Medical chose Greenlight Guru’s connected, purpose-built QMS solution to centralize its documentation and help their quality processes keep pace with their innovative product ...

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Case Study

Scaling SaMD Company Switches from Paper to Greenlight Guru’s eQMS Solution and Increases Efficiency While Reducing Costs

The organization made the switch from a paper-based QMS to Greenlight Guru’s eQMS solution and was able to save the equivalent of one full-time employee’s salary by streamlining ...

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Case Study

European IVD Startup Gets Fast, Accurate Clinical Data with Greenlight Guru's EDC System

Obtaining critical clinical data is essential to the startup’s goal of getting their in vitro diagnostic device to market. Greenlight Guru's EDC solution was easy to set up, ...

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Global Medical Device Podcast

Exploring Breakthrough Device Designation

Episode 333

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Global Medical Device Podcast

Regulatory Strategy and the Advantage of Diversity in MedTech

Episode 332

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Webinar

How to Validate an Electronic Data Capture Setup for a Medical Device Clinical Investigation

Join us and discover best practices to validate an EDC system as well as your study setup to avoid discrepancies, compliance issues and ensure data integrity and accuracy.

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Checklists and Templates

Validation Toolkit

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Webinar

Busting Mythconceptions about FDA’s Refuse-to-Accept Policy for Cybersecurity

Informative webinar where participants will learn how to confidently navigate the complexities of FDA cybersecurity requirements and enhance medical device submission strategies.

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Global Medical Device Podcast

28 Days To Save The World - True Quality Roadshow

Episode 331

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Global Medical Device Podcast

3P510k: What Is a 510k 3rd Party Review & What are the Benefits?

Episode 330

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Webinar

Preparing Your Technical Documentation under MDR: Proven Tips & Techniques

Free webinar presenting proven techniques and tips for medical device companies to prepare technical documentation per Annex II and Annex III of EU MDR, as well as ways to respond ...

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Thought Leadership Article

Fifteen Questions to Ask QMS Software Vendors in the Medical Device Industry

By Etienne Nichols, Quality Digest

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Global Medical Device Podcast

The Right Way to Start a QMS: When, How, & What

Episode 329

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Global Medical Device Podcast

FDA Guidance on Artificial Intelligence (AI) in Medical Devices

Episode 328

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Global Medical Device Podcast

Understanding the ROI of an eQMS

Episode 327

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Global Medical Device Podcast

CSA vs. CSV: Modern Validation for Modern MedTech

Episode 326

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Global Medical Device Podcast

The Role of dFMEA in Risk Management for Medical Devices

Episode 325

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Global Medical Device Podcast

Management Responsibility: The most important part of a QMS

Episode 324

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Webinar

Developing IEC 62304 Compliant Software: Proven Tips & Best Practices

Free webinar for medical device professionals to gain the knowledge and strategies necessary to successfully implement IEC 62304 to ensure compliance, while developing superior ...

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Checklists and Templates

Class 3 Medical Device Content Bundle

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Checklists and Templates

Class 2 Medical Device Content Bundle

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Checklists and Templates

Class 1 Medical Device Content Bundle

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eBook

eQMS Buyer’s Guide: Making the Business Case for a New QMS Solution

Step-by-step guide to building the business case for your new eQMS solution, pitching it to management, and making the transition from your old QMS to one that will help your ...

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Case Study

How Hart Biologicals Cut Audit Prep Time in Half with a Purpose-Built QMS Platform

Tired of an inefficient and ineffective paper-based QMS, Hart Biologicals chose Greenlight Guru’s connected, purpose-built QMS solution to drastically improve its audit ...

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Events

2023 Risk Management True Quality Summit Series

With nearly every medical device regulatory agency placing risk management front and center it’s increasingly important understand what the regulations are asking for and which ...

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Checklists and Templates

Clinical Evaluation Toolkit

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Webinar

Global UDI Update: Including FDA “Devices Not in GUDID” Letters and EU Legacy Device Extension

Free webinar providing an update on global UDI regulations, including FDA initiatives to improve GUDID data quality and the recent EU Legacy Device Amendment, as well as UDI ...

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Global Medical Device Podcast

The Combination Products Handbook

Episode 323

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Global Medical Device Podcast

Leaning into Lean Documentation

Episode 322

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Global Medical Device Podcast

Cybersecurity and the Future of MedTech

Episode 321

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Global Medical Device Podcast

Ad Promo and The Difference in Regulatory & Legal

Episode 320

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Webinar

Showing Substantial Equivalence in All Types of 510(k)s: Minimizing Time & Cost to Market

This free webinar will help medical device companies understand the regulatory expectations for substantial equivalence and how to successfully demonstrate it in all types of ...

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Webinar

How to Design the Optimal eCRF for MedTech Clinical Investigations

This free webinar covers 10 of the most important factors to consider when designing the optimal eCRF for clinical investigations.

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Webinar

Understanding the ROI of an eQMS Solution

Free webinar providing valuable insights and proven best practices in three key areas defined in this recent study: improving organizational efficiencies, mitigating risk, and ...

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Checklists and Templates

Checklist for Protecting your IP throughout the MedTech Lifecycle

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Global Medical Device Podcast

How AI Can Help You Manage Risk

Episode 319

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Checklists and Templates

What to Include in Your Quality Assurance Agreement with a Distributor

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Global Medical Device Podcast

The Tools that Make Clinical Investigations

Episode 318

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Webinar

Implementing Risk Throughout the Entire Product Lifecycle

This free webinar provides best practices and actionable tips for MedTech companies to effectively manage risk across the entire medical device lifecycle.

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Events

A New Era of Risk Management for MedTech | Greenlight Guru Product Launch Event

Watch the live product launch where we unveil Greenlight Guru's Risk Solutions, revolutionizing risk management and transforming the way you work.

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Global Medical Device Podcast

Complaint Handling with Medical Device Guru, Brittney McIver

Episode 317

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Global Medical Device Podcast

Avoiding Potential Issues with your 510(k) Submission

Episode 316

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Global Medical Device Podcast

Meet a Guru: Brittani Smith

Episode 315

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Webinar

How To Gain Better Access to Healthcare Decision Makers

In this free webinar, you’ll get a chance to hear from a hospital executive, a MedTech sales leader, and MedTech startup “nerd” as they discuss strategies for navigating the ...

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Checklists and Templates

QMS Implementation Checklist Template

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Checklists and Templates

Quality Management System (QMS) Software Vendor Checklist

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Global Medical Device Podcast

Why Building Supplier Relationships Is So Important

Episode 314

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Global Medical Device Podcast

Systematic Literature Review for EU MDR

Episode 313

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Events

To Commercialization & Beyond True Quality Summit Series

Ensuring compliance looks different depending on what phase you’re in (pre-market, post-market, or somewhere in between). That's why we're hosting a virtual summit with ...

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Webinar

How to Show ROI on Your Clinical Evidence

This free webinar presented by Jon Bergsteinsson, SMART-TRIAL by Greenlight Guru co-founder, and Autumn Lang, PhD, RAC, Director of Clinical Affairs at VeriSkin Inc. covers ...

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Webinar

Pre-market Medical Device Studies and Good Clinical Practice - Strategies for Success

Jon Bergsteinsson and ISO14155 SME Maria Nyåkern will discuss strategies to successfully fulfill GCP requirements for medical device companies.

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Global Medical Device Podcast

Building Your Design Controls (and Pitfalls to Avoid)

Episode 312

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Global Medical Device Podcast

Most Common Problems Found During FDA Inspections in 2022

Episode 311

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Global Medical Device Podcast

V&V Activities from a Verification Engineer POV - How Hard Could It Be?

Episode 310

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Global Medical Device Podcast

Understanding the 'Compliance Manager' Role

Episode 309

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Case Study

Avenda Health Gets SaMD Product to Market Easier with Greenlight Guru’s Purpose-Built QMS

“Greenlight Guru’s Design Controls module is powerful and the traceability present across the entire QMS is my favorite part about the software. It makes remote collaboration so ...

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Case Study

Oticon Medical Continues Striving for Clinical Excellence

How SMART-TRIAL by Greenlight Guru is helping Oticon Medical, industry-leading medical device manufacturer of hearing aids, and why they have remained loyal customers for years.

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Webinar

Modernizing Your QMS to Reduce Risk, Improve Quality & Drive Innovation

This free webinar presented by MedTech industry expert, Barret Mueller, to learn what a modern QMS is and what medical device companies should be looking for in a QMS solution.

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Checklists and Templates

ISO 14971:2019 Gap Analysis Tool

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Checklists and Templates

15-in-1 MedTech Template Bundle

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Checklists and Templates

General Safety and Performance Requirements (GSPR) Gap Assessment

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Case Study

How a Class III Device Company Passed Their ISO 13485:2016 Re-Certification Audit with a Modern QMS and Industry Expertise

“The biggest reason we chose Greenlight Guru was that their eQMS is designed for device manufacturers and developers. It is very specific to our needs”

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Webinar

Refuse to Accept (RTA) & Additional Information Requests (AIR): How to Avoid Problems with Your Medical Device Submission

During this webinar we will review the available RTA checklists and participants will learn how to design a submission that will pass administrative review and avoid receiving an ...

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Global Medical Device Podcast

DHF vs. DMR vs. DHR: Understanding the Differences & How They Interact

Episode 308

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Global Medical Device Podcast

How Communication Affects the Outcomes of Quality Activities

Episode 307

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Global Medical Device Podcast

Part 2: The Theranos Loophole & Lab Developed Tests

Episode 306

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Global Medical Device Podcast

Part 1: The Theranos Loophole & Lab Developed Tests

Episode 305

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Global Medical Device Podcast

Implementing an eQMS after Switching from Paper

Episode 304

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Global Medical Device Podcast

Essentials of Sterilization for Med Device Professionals

Episode 303

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Global Medical Device Podcast

UDI: 101

Episode 302

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Global Medical Device Podcast

Quality Myths and Lessons Learned

Episode 301

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Global Medical Device Podcast

Determining User Needs for Your Medical Device

Episode 300

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Global Medical Device Podcast

Fraud in the Healthcare Industry & the Role of Whistleblowers

Episode 299

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Global Medical Device Podcast

Auditing the Auditor

Episode 298

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Global Medical Device Podcast

What is MedTech Lifecycle Excellence?

Episode 297

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Webinar

Alternatives to PMCF Clinical Investigations

In this webinar, leading MedTech experts from QServe and SMART-TRIAL by Greenlight Guru share their insights on alternatives to PMCF clinical investigations and suggest ways ...

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eBook

Ultimate Guide to Postmarket Surveillance of Medical Devices

This eBook of the Ultimate Guide to Postmarket Surveillance covers the regulations that manufacturers must follow, along with best practices and tips for carrying out PMS ...

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eBook

Ultimate Guide to ISO 14155:2020 for Medical Devices

The ultimate guide about ISO 14155:2020 and Good Clinical Practices (GCP) packed with valuable insights into how to conduct and plan a clinical investigation.

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Checklists and Templates

5 Tips for IEC 60601 Submissions

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Webinar

How to Create Your DHF/TF & RMF for a Hardware or Software Medical Device

This free webinar provides a "how to" for DHF/TF and RMF creation for both SaMD and hardware devices.

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Webinar

The Ugly Truth About Paper-Based QMS - Making the Switch to eQMS

This webinar will highlight why MedTech companies should be concerned about what tools they use to maintain traceability - from an economical, regulatory, and ethical standpoint, ...

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Checklists and Templates

EU MDR Economic Operators Guidance Document

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eBook

2023 MedTech Industry Benchmark Report

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Checklists and Templates

5 "Whys" for Root Cause Analysis Technique Cheat Sheet

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Webinar

MDR by the Numbers: Leveraging New Data for Implementation Planning

Free webinar covering the results of research on recent MDCG guidance, industry and Notified Body surveys, and personal interviews with regulatory stakeholders on first hand ...

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Case Study

Tenacore Passes ISO 13485:2016 Recertification Audit with the Help of Greenlight Guru’s Modern Platform

"It’s scalable, it’s repeatable, and it’s audit-ready."

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Webinar

How to Use Clinical Data for Medical Device Submissions in both EU & US

In this free webinar medical device experts from Avania and SMART-TRIAL by Greenlight Guru share advice and insights on how medical device manufacturers can optimize clinical ...

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Webinar

How to Collect PMCF Data for Lower Class Devices and WETs

In this free webinar, SMART-TRIAL‘s PMCF expert, Jón Bergsteinsson, teams up with CEO of Evnia, Efstathios Vassiliadis, to present you with a simple, yet powerful tool, to collect ...

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Webinar

eConsent in Medical Device Clinical Investigations

This webinar will answer the most common questions on eConsent in medical device clinical investigations, with Jon Bergsteinsson and Pall Johannesson co-founders of SMART-TRIAL by ...

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Events

2023 State of Medical Device True Quality Summit Series

Greenlight Guru's annual 2023 State of Medical Device Industry Report is coming to help you understand the strategies, tactics, and technologies used today to accelerate ...

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Global Medical Device Podcast

The Best of Jon & Mike Through the Years

Episode 296

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Global Medical Device Podcast

CDRH Proposed Guidance for FY 2023

Episode 295

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Case Study

Monitored Therapeutics, Inc: Building an Audit-ready QMS in 3 Months

“Purchasing Greenlight Guru was the best decision for our needs. Their easy-to-use eQMS, SOP Templates, and expert Guru guidance were key to us being able to successfully navigate ...

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Checklists and Templates

CAPA Report Template

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Global Medical Device Podcast

Future of the Emergency Use Authorization (EUA): COVID, Monkeypox & Beyond

Episode 294

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eBook

How to Plan a Clinical Data Management Setup for EDC Systems

Access this free guide on how to plan a clinical data management setup for EDC Systems.

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Webinar

5 Tips for Designing a Medical Device Study under US FDA Requirements

Register for this free webinar presented by clinical data expert and co-founder of SMART-TRIAL by Greenlight Guru, Páll Jóhannesson, and senior director of clinical operations at ...

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Global Medical Device Podcast

The Future of Healthcare & How We Get There

Episode 293

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Global Medical Device Podcast

What "Exempt" Means with Respect to Medical Devices & Regulatory

Episode 292

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Global Medical Device Podcast

Developing a Regulatory Strategy

Episode 291

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Checklists and Templates

Quality Event Template Package for CAPAs, Complaints & Nonconformities

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Checklists and Templates

Clinical Evaluation Procedure Template

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Checklists and Templates

Checklist to Evaluate Your Quality Control Process

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Checklists and Templates

Design Transfer to Manufacturing

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Webinar

FDA Digital Health Updates: What changed in 2022 and what should you expect in 2023?

This free, in-depth webinar, presented by regulatory experts Kevin Go and Allison Komiyama, will discuss recent regulatory developments in the Digital Health space, how to apply ...

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Global Medical Device Podcast

We Achieved ISO Certification! Now what?

Episode 290

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Global Medical Device Podcast

The Future of Reprocessed Used Medical Equipment

Episode 289

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Global Medical Device Podcast

The Importance of Cervical Cancer Screening in the U.S.

Episode 288

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Global Medical Device Podcast

Customer Discovery for Medical Device Companies

Episode 287

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Global Medical Device Podcast

EUA and the Impending Transition

Episode 286

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Global Medical Device Podcast

Common QMS Mistakes SaMD Companies Make

Episode 285

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Global Medical Device Podcast

Design Assurance: The Unsung Heroes of R&D

Episode 284

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Global Medical Device Podcast

Lessons from an Industry Leader: Playing the Long Game of MedTech

Episode 283

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Global Medical Device Podcast

7 Common 510(k) Mistakes and How to Avoid Them

Episode 282

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Global Medical Device Podcast

Best Practices for Clinical Evidence Management

Episode 281

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eBook

7 Principles to Designing an eCRF

A free guide supplying medical device manufacturers with 7 best practices for how to design an electronic case report form.

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eBook

The Medical Device Sample Size Cookbook

In-depth guide on the process of sample size calculation for medical device studies.

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eBook

Ultimate Guide to Device Class Requirements under EU MDR

In-depth guide on medical device classification and requirements under EU MDR.

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Webinar

Regulatory Due Diligence: Why Pay for Information You Can Get for Free?

In this free, interactive webinar industry expert Michael Drues, PhD, explains what regulatory due diligence is for medical device professionals and how to do it, as well as how ...

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Checklists and Templates

Medical Device Reporting (MDR) Decision Tree

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Webinar

Monetizing Software: The Challenges of Commercialization & How to Overcome Them

Join us for a live webinar as industry experts Shawnnah Monterrey, CEO of BeanStock Ventures, Kate Burns, Senior Software Product Manager at Arthrex, and Chris DuPont, CEO of ...

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Webinar

How to Prepare for IVDR

Free, educational webinar covering pertinent details and established best practices on how to prepare your QMS, technical, and clinical documentation for the upcoming IVDR ...

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Events

The Future of QMS Requirements True Quality Summit Series

If you don’t have a world-class Quality Management System, you may be falling behind. Your QMS can go beyond compliance as you work to enable a culture of True ...

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Webinar

Extending IEC 62304’s Software Lifecycle Principles to Electrical and Mechanical in Medical Device Design

In this free, in-depth webinar, Satyajit ‘Sat' Ketkar will explain how these principles can and should be applied to all functions of a medical device, specifically electrical and ...

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eBook

Ultimate Guide to Supplier Management for Medical Device Companies

Good supplier management is critical to marketing a medical device. This comprehensive guide covers everything you need to know about suppliers and purchasing controls.

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Global Medical Device Podcast

Building Your Regulatory Strategy for Commercialization

Episode 280

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Global Medical Device Podcast

Packaging Validation Best Practices

Episode 279

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Global Medical Device Podcast

Overcoming Submission Deficiencies due to Biocompatibility

Episode 278

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Global Medical Device Podcast

Does Your CAPA Process Need a CAPA?

Episode 277

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Global Medical Device Podcast

UDI and the Current State of Global Implementation

Episode 276

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Global Medical Device Podcast

The Changing Job Market & How it Affects Careers for MedTech Quality Professionals

Episode 275

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Global Medical Device Podcast

Digitizing your SaMD Testing

Episode 274

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Global Medical Device Podcast

Examining FDA’s Refusal to Accept (RTA) Policy and Guidance

Episode 273

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Global Medical Device Podcast

Guerilla Tactics for Quality Leadership

Episode 272

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Global Medical Device Podcast

Preventing the Death of Medical Device Sales

Episode 271

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Webinar

Usability Testing: Why can’t we get it right?

This free in-depth webinar presented by Michael Drues, Ph.D., President of Vascular Sciences, will use actual devices as case studies to take a critical look at the way we do ...

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Webinar

Clinical Considerations for Software and Artificial Intelligence (AI) / Machine Learning (ML)

Join Proxima Clinical Research’s subject matter expert, Director of Regulatory Affairs, Isabella Schmitt, MBA, RAC, who will expand on clinical considerations for software and ...

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Webinar

Connecting Computer System Validation to Daily Operations

Register for this free, in-depth webinar where Carlos Almeida, District Manager & Vice President, Engineering at SPK and Associates, will walk you through how to manage electronic ...

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eBook

Ultimate Guide to UDI for Medical Devices

A comprehensive guide to UDI (Unique Device Identification) for medical device manufacturers.

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Events

Global MedTech Regulatory Trends: True Quality Summit Series

MedTech’s global regulatory landscape has changed drastically over the last decade. Policies are evolving across the globe and more programs and processes are being ...

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Webinar

How to Ensure Your State of Affairs for EU MDR is State of the Art

Register for this free, in-depth webinar as we discuss how State of the Art, in context of the formal MDR and MEDDEV references, impacts Technical Documentation, Risk Analysis, ...

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Webinar

Considerations for Building Your Own Cloud Device: Regulations, Privacy & Cybersecurity

Register for this free webinar presented by Abbas Dhilawala, CTO of Galen Data, who will describe these challenges and provide considerations that are critical for success.

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Thought Leadership Article

Three Things MedTech Firms Need to Do for 'True Quality'

By Nick Tippmann, Medical Product Outsourcing

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Thought Leadership Article

Top Hiring and Recruiting Tips for Med-Tech Companies

By Nick Tippmann, Medical Product Outsourcing

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Thought Leadership Article

True Quality Experts Weigh in on MedTech Future Trends

By Nick Tippmann, Medical Product Outsourcing

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Webinar

MDR Transition and Tech File Changes: What Medical Device Companies Need to Know

Register for this free, in-depth webinar presented by Rook Quality Systems Sr. Quality Manager Chandler Thames who will expand on the new MDR requirements, and provide key ...

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Global Medical Device Podcast

Shifting Sands of SaMD Cybersecurity Regulations

Episode 270

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Global Medical Device Podcast

Early Stage Territory Planning for Medical Device Companies

Episode 269

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Global Medical Device Podcast

Regulatory & Quality Perspectives of 3D Printing in the Medical Device Industry

Episode 268

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Global Medical Device Podcast

What Impact Does a QMS & Regulatory Have on Fundraising and Pre-money Valuation?

Episode 267

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Thought Leadership Article

Finding from Greenlight Guru's Benchmark Survey of 519 Medtech Professionals

By Etienne Nichols, Project Medtech Podcast

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Thought Leadership Article

Supplier Quality Management: What MedTech Manufacturers Need to Know

By Nick Tippmann, Med-Tech Innovation

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Thought Leadership Article

Three Lessons from True Quality 2022

By Nick Tippmann, 24x7 Magazine

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Webinar

Integrating Cloud & Modern Computing Technologies into the Operation of Your Medical Device

A free, in-depth webinar covering integrating cloud and other modern computing technologies into the operation of medical devices and what cloud computing can teach us about the ...

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eBook

Ultimate Guide to Software as a Medical Device (SaMD)

A comprehensive guide to software as a medical device (SaMD) packed with insights into how these products are regulated and what manufacturers should expect when building one.

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Global Medical Device Podcast

Early Feasibility Studies in Latin America

Episode 266

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Global Medical Device Podcast

Software Bill of Materials (SBOMs) & Cybersecurity in the Medical Device Industry

Episode 265

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Global Medical Device Podcast

Approaching Cybersecurity & Usability as a SaMD Company

Episode 264

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Global Medical Device Podcast

The Future of Lateral Flow Test Technology

Episode 263

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Global Medical Device Podcast

Building a Culture of Quality

Episode 262

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Global Medical Device Podcast

Bringing Medical Devices Into The Home

Episode 261

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Global Medical Device Podcast

Demystifying the De Novo Process

Episode 260

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Global Medical Device Podcast

Challenges for Regulatory Submission: EU vs. US

Episode 259

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Global Medical Device Podcast

From Startup to Industry Leader: LIVE RECORDING AT SCBIO CONFERENCE

Episode 258

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Global Medical Device Podcast

The Future of Cybersecurity

Episode 257

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Global Medical Device Podcast

Achieving Operational Readiness through Good Project Management

Episode 256

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Global Medical Device Podcast

Bridging the Gap between Medical Devices and Clinical Data

Episode 255

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Webinar

Bridging the Gap Between Development and Regulatory Teams

A free, in-depth webinar covering the intersection and friction between development and regulatory teams, with a focus on remedies in the form of processes, tools and approaches, ...

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Webinar

How to Survive an FDA Inspection

A free, in-depth webinar covering some preventative actions that a medical device company can take to minimize the possibility of receiving a 483 which in some cases could result ...

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Webinar

Special Controls: What Are They & How Can We Use Them To Our Advantage?

This free in-depth webinar presented by Michael Drues, Ph.D., President of Vascular Sciences, will cover the basics of special controls, how to know if your device needs them and ...

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Webinar

How to Proactively Predict & Mitigate Risk throughout the Supply Chain

A free, in-depth webinar covering proactive strategies for predictive risk mitigation throughout the supply chain based on core principles of Risk Based Methodologies as it ...

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Global Medical Device Podcast

Navigating the Medical Device Single Audit Program (MDSAP)

Episode 254

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eBook

Selecting the Ideal PMCF Activity

Ultimate guide supplying medical device manufacturers with an overview of both generic and specific PMCF activities, and guidance on when and how to include them in your PMCF plan.

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Global Medical Device Podcast

Bringing Augmented Reality MedTech to Market

Episode 253

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eBook

Ultimate Guide to Clinical Evaluation of a Medical Device in the EU

A four-part comprehensive guide to help manufacturers understand the essentials of clinical evaluation for medical devices in the European Union (EU).

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Global Medical Device Podcast

Making Your Informational Meetings With FDA Valuable & Worthwhile

Episode 252

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Webinar

Top Things You Should Know When Developing Software as a Medical Device (SaMD)

A free, in-depth webinar presented by Shawnnah Monterrey of Beanstock Ventures who will provide a detailed overview of SaMD, the latest updates to the regulations, and how to ...

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Webinar

Key Pitfalls To Avoid In Medtech Clinical Data Collection

A free, in-depth webinar presented by clinical data experts Páll Jóhannesson and Jón Bergsteinsson from SMART-TRIAL who will help you avoid common pitfalls that make your ...

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Thought Leadership Article

Three Things You Need to Know About FDA QSR and ISO 13485 Harmonization

By Etienne Nichols, MedTech Intelligence

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Global Medical Device Podcast

Building Your Bill of Materials (BOM) to Accommodate Crossfunctional Needs

Episode 251

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Global Medical Device Podcast

QMSR: The Future of FDA's Quality Management System Regulation for Medical Devices

Episode 250

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Global Medical Device Podcast

How Medical Device Intellectual Property Protection Varies by Sector

Episode 249

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Global Medical Device Podcast

Human Factors & Risk Management: What's Needed & Why?

Episode 248

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Webinar

Letter-to-File 101: Are You Sure You're Preparing Yours Correctly?

A free in-depth webinar presented by Michael Drues, Ph.D., President of Vascular Sciences, covering the basics of how to prepare a letter-to-file the right way in order to avoid a ...

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Webinar

Is Regulation Necessary for Quality? How to Improve Your Product & Bottom Line with Compliance & a QMS

A free, in-depth webinar exploring how regulations and standards contribute to the improved safety and overall quality of medical products and directly affect cost and profit.

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Global Medical Device Podcast

What are the Opportunities for Improvement (OFI) for Quality?

Episode 247

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Checklists and Templates

How To Prepare An FDA Pre-Submission

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Checklists and Templates

Periodic Safety Update Report Template

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Global Medical Device Podcast

Overcoming Barriers to Receiving 510(k) Clearance: One Company's Go-to-Market Triumph

Episode 246

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Webinar

Building Your BOM: 3 Ways To Manage Your Product Information With Full Traceability

A free, in-depth webinar exploring a more efficient process to control and collaborate on product development to streamline work for faster submissions and continuous ...

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Global Medical Device Podcast

How To Select A Contract Manufacturer

Episode 245

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Global Medical Device Podcast

A Regulatory Gap Analysis of FDA's Systems & Policies

Episode 244

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Global Medical Device Podcast

Tips For Being Prepared Post-EUA (Emergency Use Authorization)

Episode 242

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Events

True Quality 2022

True Quality 2022, Greenlight Guru's inaugural conference, is coming to San Diego June 6-8th. Learn, connect, and find inspiration at the must-attend experience for ...

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Events

2022 State of Medical Device True Quality Summit Series

Greenlight Guru's annual State of Medical Device Product Development and Quality Management Report is coming to help you understand the strategies, tactics, and technologies ...

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Webinar

UDI Product Data and EUDAMED, Get Onboard!

A free, in-depth webinar covering best practices for UDI preparations and the future potential impacts to medical device manufacturers as EUDAMED requirements are becoming ...

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Thought Leadership Article

The End of EUA Is Coming Soon

By Jon Speer, Medical Product Outsourcing

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Webinar

How to Ace your Internal Audits in 2022

A free, in-depth webinar explaining how to conduct internal audits of core QMS functions and cross-functional collaboration methods you can use to benefit your product, QA/RA, ...

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Global Medical Device Podcast

Understanding the UDI System for Medical Devices

Episode 241

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Events

Raising Capital True Quality Summit Series

The Raising Capital True Quality Summit Series is designed to help early-stage medical device, MedTech, and digital health company ...

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Global Medical Device Podcast

How Augmented Reality (AR) Is Revolutionizing Healthcare

Episode 239

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Global Medical Device Podcast

Why FDA Is Prioritizing Clinical Decision Support Software & Why You Should Care

Episode 238

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Global Medical Device Podcast

Why Usability Matters

Episode 237

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Webinar

How to Effectively Implement the New ISO 14971:2019 & Maintain Your Current Risk File

Free, in-depth webinar covering various key changes to ISO14971 and practical approaches for implementation of the new standard for both new products and legacy products.

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Case Study

How Puzzle Medical is Putting Together the Pieces for Success with Greenlight Guru

"Greenlight Guru was instrumental in implementing our quality system. With them, we can bring safer, higher-quality medical devices to success while maintaining a quality ...

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Webinar

Notified Body + Manufacturer Face-off: Inside Scoop from Both Sides on How to Address MDR Misalignment

A free, in-depth webinar covering the inside scoop from off-the-record interviews held with both manufacturers and notified bodies to identify areas of misalignment and ...

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Webinar

Breakthrough Device Designation & Its Impact on Reimbursement

A free, in-depth webinar covering the benefits and risks associated with FDA Breakthrough Designation and what it means for reimbursement, FDA interactions and time to ...

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Thought Leadership Article

4 Red Flags Investors Look For When Vetting Your Medical Device Company

By Nick Tippmann, MedTech Intelligence

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Thought Leadership Article

Risk Management for Medical Devices

By Wade Schroeder, Quality Digest

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Global Medical Device Podcast

A Special Glimpse into Medtronic's Recent Developments in Spine & Biologics Technology

Episode 236

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Global Medical Device Podcast

What Are The Top Compliance Issues Plaguing Medical Device Manufacturers?

Episode 235

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Global Medical Device Podcast

Setting the Record Straight on Usability & Human Factors

Episode 234

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eBook

25 FAQs (& Answers) about ISO 15223-1:2021 Fourth Edition

A comprehensive list of most frequently asked questions and their answers about ISO 15223-1:2021 Fourth Edition, the latest version of the international standard for the ...

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Global Medical Device Podcast

Project Management for Product Development of Medical Devices

Episode 233

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Webinar

The “New” 510k: How Do You Show Substantial Equivalence Without Using A Predicate?

A free, in-depth webinar covering the “new” safety and performance based 510k (sp510k).

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eBook

Ultimate Guide to QA & RA in Medical Device 3D Printing

A white paper to guide users in the medical device industry through every stage of the product development process, from evaluating manufacturing methods and 3D printing ...

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Global Medical Device Podcast

Assessing the Global Regulatory Landscape

Episode 232

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eBook

The Risk Management + Design Controls Connection: What Device Makers Need to Know

A valuable resource to help medical device manufacturers bridge the connection between design control and risk management processes in order to design, develop, manufacture, ...

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Global Medical Device Podcast

Quality Insights from a 40+ Year Veteran of the Medical Device Industry

Episode 231

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Case Study

How a Partnership with Greenlight Guru is Making This Dental Device Manufacturer Smile

“Partnering with Greenlight Guru provides you with a team that’s on your side, who are all medical device industry pros and understand what companies like ours go ...

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Case Study

How The Partner Ecosystem Has Been Key To Market Success For Spark Biomedical

“Having partners with common values is just as important as the product or services themselves.”

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Webinar

The Power of 3D-Printed Medical Devices: Proven Regulatory Strategies & Quality Recommendations to Use for Additive Manufacturing

A free, in-depth webinar covering various additive manufacturing methods and 3D printing technologies companies can use for making medical devices, validating workflows, and ...

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Global Medical Device Podcast

When to Throw the Least Burdensome Flag on FDA

Episode 230

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Webinar

Tips & Tricks for Customizing a Clinical Trials Program for your Medical Device, IVD, or Digital Therapeutic that Satisfies Regulators, Investors & Patients

A free, in-depth webinar covering what to expect and do for a successful clinical trials program and market launch for Non-significant Risk (NSR) devices, IVDs, Software as a ...

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Global Medical Device Podcast

Past, Present, Future State (and World) of Quality in the Medical Device Industry

Episode 229

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Global Medical Device Podcast

Focusing on the Intent of the UDI Requirements from FDA's Final Guidance Doc

Episode 228

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Checklists and Templates

Abbreviated 510(k) Submission Checklist

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Checklists and Templates

Checklist For Selecting Suppliers + Contract Manufacturers

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Checklists and Templates

FDA Labeling Requirements Checklist

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Checklists and Templates

Checklist: Premarket Submission Documentation for Devices Containing Software

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Events

Get to Market True Quality Summit Series

Whether you’re bringing your first device to market, or you have launched multiple already, our upcoming True Quality Summit Series is for you. There’s a variety of ...

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Events

Risk Management True Quality Summit Series

The Risk Management True Quality Summit Series will help quality, regulatory and product development professionals and executives ...

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Global Medical Device Podcast

Addressing the 'Who, What, When' of Quality in the Medical Device Industry

Episode 227

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Webinar

Human Factors Engineering: The Worldwide Guide for Medical Device Manufacturers

Free, in-depth webinar covering the human factors engineering process and how to comply with the applicable regulatory requirements of the US, UK, EU, and other international ...

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Global Medical Device Podcast

Meet a Guru: Maryann Mitchell

Episode 226

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Global Medical Device Podcast

Why Storytelling Matters for Medical Device Companies

Episode 225

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Webinar

Demystifying the Breakthrough Device Designation (BDD) & Safer Technologies (STeP) Processes

A free, in-depth webinar covering BDD and STeP application processes and why getting these designations early in the regulatory process can help clear a device’s pathway to ...

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Global Medical Device Podcast

A Breakthrough Device that Aims to Prevent Osteoporosis

Episode 224

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Global Medical Device Podcast

Understanding FDA's New Intended Use Rule and its Implications

Episode 223

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Webinar

5 Key Points to Consider in Design Transfer of Medtech

Free, in-depth webinar presented by Doug Browne, Director of Mechanical Engineering and Design Transfer at Sunrise Labs, and Ted Trask, Director of Corporate QA/RA at ...

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Checklists and Templates

Checklist for Structuring Your Technical Documentation

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Global Medical Device Podcast

eQMS in Academia: Practical Learning for Biomedical Engineering Students

Episode 222

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Webinar

10 QMS Musts for SaMD and Devices Featuring Software (and how to best utilize for product & team success)

A free, in-depth webinar covering the best practices for setting up an agile QMS which can be adapted and optimized concurrently with software as a medical device (SaMD) ...

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Checklists and Templates

Approved Supplier List Form Template

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Global Medical Device Podcast

Tips for Running Better Management Reviews

Episode 221

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Webinar

FDA vs. EU Regulatory Pathways: Factors Every Startup Must Consider with Go-to-Market Strategy

Free, in-depth webinar presented by regulatory experts from the Greenlight Guru Regulatory Advisory Board, where they will compare and contrast FDA versus EU regulatory ...

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Global Medical Device Podcast

Meet a Guru: Ryan Behringer

Episode 220

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Global Medical Device Podcast

Navigating the MedTech Cybersecurity Ecosystem

Episode 219

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Thought Leadership Article

EU MDR Preparedness: How Is COVID-19 a Factor?

By Jon Speer, Medical Product Outsourcing

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Global Medical Device Podcast

Managing Clinical Data Activities

Episode 218

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Thought Leadership Article

How a Medical Device QMS Can Lead to More Efficient and Sustainable Diagnostic Tests

By Brandon Henning, Medical Product Outsourcing

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Global Medical Device Podcast

Explaining the Role of Importer under EU MDR

Episode 217

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Webinar

Attention ⚠️ ISO 15223-1 4th Edition is Almost Here: How to Update your Medical Device Labeling to Comply with the New Requirements

This free, in-depth webinar will cover the latest updates of ISO 15223-1 4th Edition to help participants understand the full scope of changes and uncover actionable ...

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Global Medical Device Podcast

Preparing Your Pre-Submission with the Content FDA Wants to See

Episode 216

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Global Medical Device Podcast

How RADx Tech II Program is Fast-Tracking COVID-19 Technologies to Market in 2021

Episode 215

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Global Medical Device Podcast

How New Training Partnership is Advancing Medical Device Knowledge & Professional Development

Episode 214

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Global Medical Device Podcast

Top 3 Most Cited Issues in Medical Device Inspections from FDA FY2020

Episode 213

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Global Medical Device Podcast

How Mindset Training Can Help Your Team Operate at Peak Performance

Episode 212

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Thought Leadership Article

Closed-Loop Traceability for FDA Compliance

By Jon Speer, Quality Digest

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Global Medical Device Podcast

Examining the HHS Proposal for Premarket Notification Exemptions

Episode 211

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Webinar

Combination Products: What Are They, Why Are They Important & Why Should Medical Device Professionals Care?

Free interactive webinar exploring ...

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Global Medical Device Podcast

Crash Course on Greenlight Guru Academy: How Medical Device Professionals Stay Ahead

Episode 210

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Global Medical Device Podcast

Building Your Brand as a Medical Device Professional

Episode 209

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Checklists and Templates

Clinical Investigation Report Checklist

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Global Medical Device Podcast

Understanding the Value of a Medical Device Guru

Episode 208

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Checklists and Templates

6 Tips for a Seamless Document Migration to Greenlight Guru

"Greenlight Guru provides an Electronic Quality Management System (eQMS) for medical device companies to ensure quality standards are met without requiring that the end ...

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Global Medical Device Podcast

Meet a Guru: Etienne Nichols

Episode 207

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Global Medical Device Podcast

Meet a Guru: Laura Court

Episode 206

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Global Medical Device Podcast

Regulatory Tips & Pointers from a Former FDA Reviewer

Episode 205

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Global Medical Device Podcast

Why Demand is so High for Regulatory & Quality Jobs (and should you take advantage?)

Episode 204

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Webinar

How to Prepare for and Manage Audits/Inspections across Global Markets

In this free, exclusive webinar event, Greenlight Guru founder Jon Speer will moderate a panel of industry experts in a lively discussion about audits and inspections.

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Global Medical Device Podcast

Comparing FDA’s Breakthrough Devices Program & Safer Technologies Program

Episode 203

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Checklists and Templates

Content Toolkit for Medical Device Startups

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Checklists and Templates

MDR & IVDR Gap Analysis Toolkit

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Global Medical Device Podcast

Why is IVDR Causing Widespread Panic throughout the Medical Device Industry?

Episode 202

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Global Medical Device Podcast

Managing Business Risk as a Medical Device Company

Episode 201

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Thought Leadership Article

Preparing for the EU’s MDR

By Nick Tippmann, Medical Product Outsourcing

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Global Medical Device Podcast

Waterfall vs. Agile: Battle of the Product Development Methodologies

Episode 200

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Global Medical Device Podcast

For the Love of Internal Auditing

Episode 199

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Global Medical Device Podcast

Similarities & Differences between In Vitro Diagnostic (IVD) Devices & Medical Devices

Episode 198

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Webinar

Evaluating need for Biocompatibility Testing & Mitigating Risks when Changing your Medical Device

A free, in-depth webinar on how manufacturers can evaluate whether biocompatibility testing and risk mitigations are necessary when making changes to a medical ...

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Global Medical Device Podcast

Knowing vs. Doing as Medical Device Professionals

Episode 197

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Thought Leadership Article

What Are the Biggest Changes under EU MDR?

By Jon Speer, MedTech Intelligence

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Global Medical Device Podcast

Pivoting Operations to Meet PPE Demand during Pandemic

Episode 196

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Global Medical Device Podcast

Pros & Cons of Being a Physician turned MedTech Inventor

Episode 195

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Global Medical Device Podcast

3 Systems of Risk for Medical Devices from FDA

Episode 194

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Global Medical Device Podcast

Quality Management for IVD Devices vs Medical Devices

Episode 193

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Webinar

How to Integrate Cybersecurity into Your Existing Medical Device Development Lifecycle

A free, in-depth webinar explaining how to integrate cybersecurity into existing medical device development processes, resulting in secure products and needed artifacts for ...

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Global Medical Device Podcast

Understanding the Investigational Device Exemption (IDE) Process

Episode 192

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eBook

2021 EU MDR Preparedness Study

In this report, we wanted to provide you with a holistic ...

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eBook

State of Medical Device Quality Management and Product Development Report

Understand what today’s medical device professionals are doing or using to accelerate product development, ensure compliance, and promote quality based on original research ...

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Global Medical Device Podcast

Evaluating, Monitoring & Selecting Suppliers in the Medical Device Industry

Episode 191

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Thought Leadership Article

Using Quality as an Advantage in 2021

By Jon Speer, Medical Product Outsourcing

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Global Medical Device Podcast

Learning about the Real-world Impact of Design, Manufacturing, Quality & Culture on Patients

Episode 190

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Thought Leadership Article

Three Reasons Automation and Training Are Essential in Your Medical Device QMS

By Jon Speer, Medical Product Outsourcing

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Thought Leadership Article

What Is Quality Culture and Does Your Company Have It?

By Jon Speer, Medical Device and Diagnostic Industry

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Thought Leadership Article

Why You Must Have a Single Source of Truth for CAPA

By Jon Speer, MedTech Intelligence

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Global Medical Device Podcast

What is the Safer Technologies Program (STeP) and Can Your Device Use It?

Episode 189

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Global Medical Device Podcast

Meet a Guru: Sara Adams

Episode 188

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Case Study

How IVD Manufacturer Streamlined Production and Improved Quality Processes with an Industry-Specific QMS

"If I were to quantify it, it's days of time saved. The cost of Greenlight Guru is repaid in efficiency."

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Global Medical Device Podcast

Why the PMA Process is so Dreaded by Manufacturers in the US Market

Episode 187

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Checklists and Templates

5 Steps for Creating a Traceability Matrix

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Global Medical Device Podcast

Building a Startup in the MedTech Industry

Episode 186

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Global Medical Device Podcast

Meet a Guru: Karen Schuyler

Episode 185

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Global Medical Device Podcast

Visualizing a Medical Device through Illustrations, Animations, and other Artwork

Episode 184

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Global Medical Device Podcast

Everything you Need to Know about SaMD from an FDA Perspective

Episode 183

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Checklists and Templates

Medical Device Project Plan

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Events

EU MDR & IVDR True Quality Summit Series

Whether you've fully transitioned, are just getting started, or are planning to enter the EU market in the future, you won't want to miss this free virtual summit that covers ...

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Events

2021 State of Medical Device Virtual Summit

The two day, digital event dives into perspectives, predictions, and experiences of industry leaders and takes a deep dive into the ...

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Global Medical Device Podcast

Preparing for Remote and On-Site Inspections and Audits

Episode 182

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Global Medical Device Podcast

How does EU MDR impact your Quality Management System?

Episode 181

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Checklists and Templates

510(k) Program Comparison Chart

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Global Medical Device Podcast

Virtual Auditing in a Post-COVID World of Digital Compliance

Episode 180

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Case Study

How Delta Development Fast-tracked R&D Down to a Single Year by Implementing a Medical Device QMS

"Greenlight Guru was the only way we could get our small team to move really quickly with a QMS."

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Global Medical Device Podcast

Inside Look into ISO 14971:2019 & ISO TR 24971:2020 from the Author's Point of View

Episode 179

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eBook

Ultimate Guide to Training Management for Medical Device Companies

Comprehensive guide to help medical device companies learn about training management, including compliance requirements and proven ways to promote total competence of the ...

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Global Medical Device Podcast

Prioritizing Medical Device Reimbursement During Product Development

Episode 178

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Checklists and Templates

Total Quality Management 4-in-1 Tool

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Global Medical Device Podcast

5 Actionable Lessons Learned from the RADx Initiative by NIH

Episode 177

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Checklists and Templates

Legacy vs Best-in-Class QMS Tools Comparison Chart

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Global Medical Device Podcast

What are the Strategic Priorities for CDRH in 2021?

Episode 176

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Checklists and Templates

Change Impact Analysis Template

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Global Medical Device Podcast

Measuring the Impact of AI/ML Technologies on the Current Medical Device Landscape

Episode 174

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Webinar

Change Management and Risk Management: How do we connect the dots and what happens if we don’t?

Free interactive webinar demonstrating how to integrate change management and risk management and shares best practices using case studies from a variety of clinical specialties.

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Checklists and Templates

Change Order Template

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Global Medical Device Podcast

Post-Pandemic Readiness: Preparing for the Aftermath of COVID-19 on the Medical Device Industry

Episode 173

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Checklists and Templates

Nonconformance Report Template

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Global Medical Device Podcast

Tips to Prepare for EU MDR and IVDR as Deadlines Draw Near

Episode 172

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Checklists and Templates

Free Replay Package: 2021 Medical Device Virtual Summit

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Checklists and Templates

Checklist: 7 Steps to Comply with FDA 21 CFR Part 11

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Global Medical Device Podcast

How will Emergency Use Authorization (EUA) during Pandemic Influence Future FDA Policy Changes?

Episode 171

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Thought Leadership Article

Expert Roundup: Achieving Success in the 2021 Medical Device Landscape

By Nick Tippmann, Medical Product Outsourcing

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Thought Leadership Article

Imagine It’s 2030: What Was the Key To Business Success During COVID-19?

By David DeRam, Inside INdiana Business

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Thought Leadership Article

Traceability Requirements in EU MDR

By Jon Speer, Medical Device and Diagnostic Industry (MD+DI)

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Global Medical Device Podcast

Why SaMD Companies Should be Leveraging Pre-Submissions to FDA

Episode 170

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Checklists and Templates

Value of True Quality Infographic

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Global Medical Device Podcast

What Goes into Designing Devices for Military and Emergency Applications?

Episode 169

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eBook

Ultimate Guide to 21 CFR Part 820 — FDA's Quality System Regulation (QSR) for Medical Devices

In-depth guide covering the requirements of 21 CFR Part 820, FDA's quality system regulation for medical devices, including tips on how to comply and avoid common ...

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eBook

Ultimate Guide to Document Control

In-depth guide for medical device companies on how to control documents and improve procedures, with actionable solutions to common problems with document control activities ...

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Checklists and Templates

Training Matrix Template

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Global Medical Device Podcast

Are you Spending Enough Time Defining and Managing Requirements for your Medical Device?

Episode 168

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Checklists and Templates

Top 100 Medical Device Startups with Most Money Raised in 2020 Chart

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Thought Leadership Article

Four Essential Processes in Medical Device Risk Management

By Jon Speer, Quality Digest

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Global Medical Device Podcast

Positive and Negative Impacts of EUA on the Medical Device Industry

Episode 167

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Checklists and Templates

Biocompatibility Testing Selection Criteria

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Webinar

When Do We Need FDA’s Permission to Market Our Device and When Do We Not?

A free, in-depth webinar exploring what is and is not a regulated medical device and how manufacturers can interpret and leverage FDA's definition of a device.

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Global Medical Device Podcast

Why Biocompatibility Should be Addressed by Every Medical Device Company

Episode 166

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Checklists and Templates

Human Factors & Usability Engineering Report

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Global Medical Device Podcast

Meet a Guru: Erica Loring

Episode 165

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Checklists and Templates

Complaint Template

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Global Medical Device Podcast

What is a Multiple Function Device?

Episode 164

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Thought Leadership Article

Adopting a Data-Driven Approach to Quality with a Medical Device QMS

By Jon Speer, Medical Product Outsourcing

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Checklists and Templates

7 Steps for Writing a Nonconformance Report

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Thought Leadership Article

The Importance of Managing and Controlling Risk in the Medical Device Industry

By Jon Speer, Quality Digest

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Webinar

Best Tools & Tricks for Meeting IVDR Requirements to Obtain CE Marking

A free, in-depth webinar covering the best tools and tricks for manufacturers of in vitro diagnostic devices to meet IVDR requirements and obtain CE Marking.

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Global Medical Device Podcast

Challenges related to Home Use Devices

Episode 163

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Thought Leadership Article

Why I Left a MedTech Manufacturer For a Software Scale-Up

By Wade Schroeder, Inside INdiana Business

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Global Medical Device Podcast

Submitting a 510(k) using FDA's Safety and Performance Based Pathway

Episode 162

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Webinar

How to Implement and Maintain a Modern CAPA System while Avoiding Common Pitfalls

A free, in-depth webinar covering proven methods to improve your CAPA processes and tactical approaches you can start taking today to ensure the medical devices you design, ...

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Global Medical Device Podcast

How Jon Speer Met His Most Frequent Guest: Mike Drues

Episode 161

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Thought Leadership Article

Areas to Consider in Medical Device Risk Management

By Jon Speer, Medical Product Outsourcing

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Global Medical Device Podcast

Meet a Guru: Wade Schroeder

Episode 160

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Webinar

Insider’s look at the IEC 60601 Amendments: Detailed Guidance from Committee Member Responsible for Changes

A free, in-depth webinar covering the significant changes of the IEC 60601 Amendments and how medical device manufacturers and consultants can ...

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Global Medical Device Podcast

What are the Audit Etiquette Rules I Should be Following?

Episode 159

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Global Medical Device Podcast

Meet a Guru: Tom Rish

Episode 158

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Thought Leadership Article

Ensure Success Throughout the Entire Medical Device Lifecycle

By Jon Speer, Medical Device and Diagnostics Industry

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Thought Leadership Article

What Consumer Tech Companies Need To Know About Medical Devices In The European Union

By David DeRam, Forbes

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Global Medical Device Podcast

Addressing Clinical Trial Challenges & Concerns during COVID-19

Episode 157

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Thought Leadership Article

From the Experts: Best Practices to Ensure Device Success

By Jon Speer, Medical Product Outsourcing

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Webinar

Verification & Testing Strategies for Compliance with ISO 13485:2016, IEC 62304 / 60601-1 / 82304-1

A free in-depth webinar covering the most effective verification and testing strategies companies can implement for compliance with ISO 13485:2016, IEC 62034 / 60601-1 / 82304-1.

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Global Medical Device Podcast

Protecting the Intellectual Property of your Medical Device Technology

Episode 156

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Global Medical Device Podcast

Meet a Guru: Jesseca Lyons

Episode 155

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Global Medical Device Podcast

How to Build a QMS for a Medical Device

Episode 154

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Global Medical Device Podcast

Meet a Guru: Taylor Brown

Episode 153

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Events

The Greenlight Guru True Quality Virtual Summit

The Greenlight Guru True Quality Virtual Summit is the must-attend experience for medical device quality, regulatory, and product development professionals who drive innovation ...

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Webinar

Understanding the Medical Device Classification System: From Basics to Beyond – Using Classification to your Competitive Advantage

A free, in-depth webinar covering the medical device classification system and how companies can use it to their competitive advantage by using best practices for ...

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Webinar

How to Integrate Risk Management throughout the Lifecycle of a Medical Device in the Coming Decade

A free webinar reviewing the application of a modern approach to risk management (risk analysis, risk evaluation, risk control, overall residual risk evaluation, production and ...

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Thought Leadership Article

Best Practices for Leading Medical Device Teams During the COVID-19 Pandemic

By Jon Speer, MedTech Intelligence

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Global Medical Device Podcast

What is Regulatory Due Diligence for Medical Devices?

Episode 152

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Global Medical Device Podcast

Mass-Manufacturing a 5-in-1 Ventilator System for COVID-19 Relief

Episode 151

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Case Study

How Flexlogical Is Making Quality A Competitive Advantage By Adopting Data-driven Approach With a Medical Device QMS

"Showing traceability and documenting takes seconds in Greenlight Guru, compared to hours in a paper-based system."

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Global Medical Device Podcast

How Being Strategic During A Career Transition Can Yield The Best Opportunities

Episode 150

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Global Medical Device Podcast

Identifying the Positive and Negative Effects of COVID-19 on the Medical Device Industry

Episode 149

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Thought Leadership Article

Managing and Leading Medical Device Companies and Teams During the Pandemic

By Jon Speer, Medical Product Outsourcing

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Checklists and Templates

3 Tips for Receiving EUA from FDA

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Global Medical Device Podcast

How to Construct an Effective Regulatory Strategy

Episode 148

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Thought Leadership Article

COVID-19’s Impact on the MedTech Industry: How to Get Through

By Jon Speer, MedTech Intelligence

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Global Medical Device Podcast

What you Need to Know about Clinical Evaluation & Validation for Software as a Medical Device (SaMD)

Episode 147

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Thought Leadership Article

What You Need to Know for an Effective Risk Assessment

By Jon Speer, Quality Digest

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Global Medical Device Podcast

How to Use Artificial Intelligence & Machine Learning to Produce Better, Smarter, Safer Devices

Episode 146

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Thought Leadership Article

What Consumer Tech Companies Need To Know About Medical Devices In The US

By David DeRam, Forbes

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Global Medical Device Podcast

510(k) Tips and Answers to Frequently Asked Questions for Medical Device Companies

Episode 145

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Global Medical Device Podcast

Addressing the PPE Shortage with a No Cost Solution for Healthcare Providers

Episode 144

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Thought Leadership Article

Engineers: How to Curb Quality Myths Now

By Jon Speer, MedTech Intelligence

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Global Medical Device Podcast

[LIVE] How EU MDR Changes are Impacting the Medical Device Ecosystem

Episode 143

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Global Medical Device Podcast

How to Approach Verification and Validation for Cloud Software

Episode 142

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Global Medical Device Podcast

Fighting COVID-19: How one MedTech Company is Using UV-C Technology to Eliminate Virus & Save Lives

Episode 141

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Webinar

3 Ways Medical Device Companies Working Remote Are Leveraging QMS Software To Foster Innovation And Collaboration

This free in-depth webinar will cover how companies using turn-key, best-in-class QMS software are able to remain agile in order to innovate and outperform the ...

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Thought Leadership Article

Building a Medtech Firm on a Foundation of Quality

By Nick Tippmann, Medical Product Outsourcing

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Global Medical Device Podcast

Emergency Use Authorization (EUA) 101: What Medical Device Companies Need to Know

Episode 140

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Webinar

How Can Medical Device Companies Use The Emergency Use Authorization (EUA) To Address The Covid-19 Pandemic?

This free in-depth webinar will explore the Emergency Use Authorization — specifically in the context of COVID-19 — and how medical device companies can use it.

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Checklists and Templates

10 Ways A Modern, Cloud-Based Medical Device QMS Helps Remote Teams Stay Ahead

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Global Medical Device Podcast

How to Integrate Usability into your Medical Device

Episode 139

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Global Medical Device Podcast

[LIVE] Design Controls, Development, and Risk for Software as a Medical Device (SaMD)

Episode 138

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Global Medical Device Podcast

How to Leverage IEC 62304 to Improve SaMD Development Processes

Episode 137

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eBook

Definitive Guide to ISO 14971:2019 Risk Management for Medical Devices

Learn the most up to date recommendations and best practices from the ISO 14971:2019 standard and how you can start to use risk management as a tool - not a checkbox ...

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Webinar

Are You Sure You Know the Best Regulatory Pathway for Your New Medical Device?

This free in-depth webinar will explore all regulatory pathways to market — including the lesser-known and lesser-used ones — to help you decide which to use when for your ...

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Global Medical Device Podcast

What is the eSTAR Pilot Program and How Will it Improve FDA's 510(k) Review Process?

Episode 136

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Thought Leadership Article

Paper Processes: Three Reasons It’s a Costly Business Move

By Jon Speer, MedTech Intelligence

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Thought Leadership Article

Paper Is Expensive

By Jon Speer, Quality Digest

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eBook

Best QMS Software: Ultimate Guide To Comparing Quality Management System Solutions

The best QMS software comparison guide for medical device companies that will help you choose a quality management system solution that strategically benefits your product and ...

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Webinar

How to Use UX to Streamline Medical Device Product Cycles

A free in-depth webinar outlining a process that not only fits within the regulatory parameters, but also is so effective that it shortens the typical product development cycle ...

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Global Medical Device Podcast

How to Choose the Right FDA Regulatory Pathway for your Device

Episode 135

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Global Medical Device Podcast

How to Establish a Solid Foundation for Fundraising and Product Success by Focusing on Regulatory

Episode 134

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Thought Leadership Article

The True Cost of Paper

By Jon Speer, Medical Product Outsourcing

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Global Medical Device Podcast

4 Parts to Interviewing Candidates for Medical Device Roles

Episode 133

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Webinar

Key Considerations for SaMD Companies Developing and Commercializing Software as Medical Devices

A free in-depth webinar covering the most important items that companies must understand and put into practice when developing and commercializing SaMDs.

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Global Medical Device Podcast

5 Tips for Hiring Medical Device Advisors

Episode 132

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Thought Leadership Article

4 Powerful Ways Mindfulness Encourages Peak Performance

By David DeRam, Forbes

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Thought Leadership Article

Why Great Companies Don't Run On Spreadsheets

By David DeRam, Forbes

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Global Medical Device Podcast

2 Key Areas Missing from FDA CDRH's Regulatory Science Priorities for 2020

Episode 131

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Thought Leadership Article

3 Keys to Attracting Investors and Raising Funds for Your Med Device

By Jon Speer, Healthcare Business Today

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Thought Leadership Article

Six Mistakes to Avoid When Implementing ISO 13485

By Jon Speer, Medical Product Outsourcing

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Thought Leadership Article

5 Tips To Raise Funding For Your Medical Device

By Jon Speer, Medical Design & Outsourcing

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Thought Leadership Article

5 Tips to Raise Investor Interest and Fund Your Medical Device

By Jon Speer, Medical Product Outsourcing

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Webinar

Behind the Stats: Medical Device Product Development & Quality Management Benchmark Survey

A free in-depth webinar on industry benchmark survey findings of over 500 medical device professionals around the globe, covering the most compelling stats, biggest surprises, ...

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eBook

15 Questions to Ask QMS Software Vendors in the Medical Device Industry

Know what questions to ask software vendors that give your medical device company the necessary information to consider when selecting a QMS software solution.

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Thought Leadership Article

4 Keys to Funding Your Medical Device

By Jon Speer, MedTech Intelligence

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Webinar

Beyond Design Controls 101: Following the Regulation vs. Understanding its Intent

A free webinar covering the design control “framework” and recommendations to effectively meet their requirements. Emphasis will be placed not only on regulatory aspects but on ...

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Global Medical Device Podcast

Navigating the Twists and Turns of Change Management for Medical Devices

Episode 130

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Global Medical Device Podcast

What Is FDA's ASCA Pilot Program And How Does It Impact Medical Device Manufacturers?

Episode 129

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Webinar

Implementing Best Practice Medical Device Change Control Processes (While Avoiding Common Pitfalls)

A free webinar on how you can establish an effective medical device change control process to ensure internal consistency throughout your quality management systems and ...

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Global Medical Device Podcast

5 Myths about QA/RA Recruiting in the Medical Device Industry

Episode 128

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Global Medical Device Podcast

How to Solve the Medtech Value Equation with Quality Data

Episode 127

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Checklists and Templates

IVDR Gap Assessment Tool

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Global Medical Device Podcast

Why Supplier Quality Management Is So Important

Episode 126

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Global Medical Device Podcast

FDA is Expanding its Case for Quality Program... Should Your Company Participate?

Episode 125

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Thought Leadership Article

We’re going through changes: Major upcoming regulatory changes for manufacturers explained

By Jon Speer, Medical Plastics News

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eBook

Definitive Guide to Change Management for Medical Devices

A definitive guide on change management best practices to help medical device companies understand and manage changes to documents, products, processes and more.

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Thought Leadership Article

Top 3 Mistakes You Can Make When Adopting ISO 13485

By Jon Speer, Medtech Intelligence

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Global Medical Device Podcast

Preparing for EU MDR

Episode 124

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Thought Leadership Article

A Tsunami of Regulatory Changes is Coming

By Jon Speer, InCompliance

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Webinar

An Exclusive Look at the New Changes to ISO 14971:2019 and ISO TR 24971:2019

A free, in-depth webinar covering the new changes to ISO 14971:2019, the international standard for medical device risk management, and its companion guidance document ISO TR ...

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Checklists and Templates

MDD vs. MDR Gap Assessment Tool

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Global Medical Device Podcast

Addressing Top Questions of QA/RA Candidates on Salary, Skill Sets and Job Satisfaction

Episode 123

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Glossary

IEC 60601

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eBook

5 Do's And Don'ts When Choosing A Qms Solution For Your Medical Device Company

A guide to the top 5 recommended best practices that medical device companies should consider when choosing a quality management system (QMS) solution.

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eBook

A Complete Guide to Bringing a Medical Device to Market

A complete guide for medical device manufacturers looking for guidance on how to plan for a successful product launch and maintain regulatory compliance across global ...

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Checklists and Templates

5 Myths about PMA's (and what's actually true)

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Thought Leadership Article

Top 4 Mistakes When Implementing ISO 13485

By Jon Speer, Medical Design & Outsourcing

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Thought Leadership Article

Five Tips From Medtech Executives on the Value of Quality

By Jon Speer, Quality Digest

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Case Study

C2DX, INC. Impresses Auditors and Achieves MDSAP Certification After Implementing Medical Device QMS

"We wanted a QMS solution that was robust enough to grow with us, but simple enough to get us started."

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Webinar

Post-market Surveillance For Medical Devices And Combination Products: If A Device Is Fda Cleared Or Approved, Can We Assume It’s Safe And Effective?

In this free webinar participants will learn post-market surveillance best practices for medical devices and combination products to avoid timely and costly mistakes, as ...

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Global Medical Device Podcast

Is FDA's New 'Safer Technologies Program' Applicable To Your Medical Device?

Episode 122

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Improving Outcomes and Reducing Costs with an Intelligent Surgical Medical Device

Evan Luxon Co-founder & CEO, Centese

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Global Medical Device Podcast

Understanding the Benefit-Risk Determinations of FDA's Latest Guidance Documents

Episode 121

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Checklists and Templates

Content Toolkit for Medical Device Executive Leaders

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Global Medical Device Podcast

Leveraging Technology and Rapid Prototyping Methodologies during Product Development

Episode 120

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Webinar

How and When to Start Documenting your Formal Design Controls with DHF Ready Ideation

In this free webinar participants will learn how and when to start formal design controls to improve product development through an innovative and proven approach known as DHF ...

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Global Medical Device Podcast

Challenges with Pediatric Medical Devices

Episode 119

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Webinar

How And When To Register EU Medical Devices And Report UDI Information To EUDAMED

In this free webinar participants will learn how and when to register EU medical devices and report Unique Device Identification (UDI) information to EUDAMED, manage UDI ...

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Checklists and Templates

Content Toolkit for Medical Device QA/RA Professionals

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Checklists and Templates

Content Toolkit for Medical Device Product Developers

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Global Medical Device Podcast

Implementing Changes to SaMD under New EU MDR

Episode 118

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Global Medical Device Podcast

Career Tips for QA/RA Professionals in the Medical Device Industry

Episode 117

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Case Study

Photonicare Adopts Medical Device QMS Software to Accelerate Time to Market

“Greenlight Guru has been instrumental for us while we efficiently navigate the quality management system process and with developing our FDA submission.”

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Thought Leadership Article

The Essential Guide To Preparing Your QMS For EU MDR

By Jon Speer, The MedTech Conference

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Glossary

IEC 62304

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Global Medical Device Podcast

Right-sizing your QMS

Episode 116

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Checklists and Templates

Quality Culture Flowchart

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Webinar

How To Apply Risk Management Throughout The Product Lifecycle Of Your Medical Device

In this free webinar participants will learn how to apply Risk Management (Risk Analysis, Risk Evaluation, Risk Control, Overall Residual Risk Evaluation, Production and Post ...

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Global Medical Device Podcast

Challenges with Pediatric Medical Devices

Episode 115

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Elevating True Quality with Software Medical Device for Early Cancer Detection and Treatment

Chad McClennan President, CEO, Koios Medical, Graham Anderson CFO, Koios Medical, Patricia ...

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Global Medical Device Podcast

When Should You Start a QMS?

Episode 114

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eBook

Ultimate Guide To Agile Design And Development For Medical Devices

In-depth overview of Agile design and development processes to improve risk and quality management of medical devices that fulfill user and business needs.

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Glossary

Bill of Materials

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Glossary

Root Cause Analysis

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Global Medical Device Podcast

How General Wellness Devices Have Opened a Pandora's Box of Confusion

Episode 113

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Webinar

10 Steps To Preparing Your 510(k) Submission (And How To Avoid The Common Pitfalls)

In this free webinar participants will learn about the key steps to take when preparing a 510(k) Premarket Notification and how to avoid common pitfalls that can occur during ...

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Global Medical Device Podcast

Regulating Artificial Intelligence and Machine Learning-Based Software as a Medical Device

Episode 112

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Global Medical Device Podcast

Importance of Software Requirements in Product Development

Episode 111

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Glossary

Predicate Device

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Eliminating Subjectivity And Guesswork With A Modernized Solution To Detecting Ear Infections

Ryan Shelton Founder / CEO, PhotoniCare

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Thought Leadership Article

Not All Medical Device QMS Solutions Are Created Equal

By Evan Luxon, Centese (Greenlight Guru customer), Medical Product Outsourcing

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Thought Leadership Article

Quality Is The Heartbeat Of Your Company

By David Deram, Forbes

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Global Medical Device Podcast

4 Facts That May Surprise You About FDA

Episode 110

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Glossary

FDA Warning Letters

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Webinar

Breakthrough Designation Program: Is This An Option For My Medical Device?

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Global Medical Device Podcast

Design History File Ready Ideation: An Innovative Approach To Product Development

Episode 109

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Checklists and Templates

EU MDR: SaMD Guidance Document + Audit Gap Assessment Tool

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Global Medical Device Podcast

Looking at the Sunset of FDA's Alternative Summary Reporting Program

Episode 108

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Creating a Culture of Quality for Medical Device Companies

Devon Campbell Founder, Prodct LLC

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Global Medical Device Podcast

Challenges with MedTech Innovation

Episode 107

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Standard Operating Procedure for Medical Devices

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EU IVDR

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Technical File vs Design Dosier

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Notified Body

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Human Factors and Usability

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QMS Manual

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EU MDR: Not All Doom and Gloom

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FDA Form 483

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Live Atlanta True Quality Roadshow Panel: The Changing Quality & Regulatory Paradigm

Episode 99

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EU MDR Gap Analysis Tool

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Episode 97

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Episode 95

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Episode 94

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Episode 93

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21 CFR 803 Medical Device Reporting

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Episode 92

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When Design Input Requirements Go Wrong

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Episode 91

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Episode 89

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FDA 510(k) Database

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Episode 88

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Episode 87

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4 Reasons the Root Cause Isn't "User Error" Cheatsheet

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Checklist for Selecting Suppliers to Your Medical Device Company

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4 Methods for Root Cause Analysis Cheat Sheet

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7 Rules for Effective Medical Device Design Controls Cheat Sheet

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5 "Whys" for Root Cause Analysis Technique Cheat Sheet

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ISO 13485:2016 vs FDA 21 CFR Part 820 Full Comparison Table

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Medical Device Product Development Checklist

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FDA QSR & ISO 13485: 2016 Internal QMS Audit Checklist

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Episode 80

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Episode 79

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Risk Matrix

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Episode 66

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CORRECTIVE ACTION VS PREVENTIVE ACTION

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CORRECTIVE AND PREVENTIVE ACTION FORM

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CORRECTIVE AND PREVENTIVE ACTION REPORT

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NONCONFORMANCE MANAGEMENT

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CORRECTIVE ACTION PROCEDURE

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How to Integrate Complaint Handling and Risk Management

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How CAPA Connects to Other QMS Processes

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Design Validation vs. Clinical Evaluation: What's the difference?

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Thought Leadership Article

Why You Must Know the Difference Between 'Intended Use' and 'Indications for Use'

By John Speer, Medical Device and Diagnostic Industry

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Thought Leadership Article

4 key compliance issues for medical device companies

By Jon Speer, MedCity News

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Thought Leadership Article

Five Tips for Medical Device Engineers on FDA Design Controls

By Jon Speer, Quality Digest

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Thought Leadership Article

5 predictions for the medical device industry

By Jon Speer, MedCity News

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Thought Leadership Article

Key Challenges for Risk Management in Medical Device Development

By Jon Speer, Quality Digest

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Webinar

What You Need to Know About Medical Electrical Standards Updates

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Webinar

Advanced Strategies and Tactics for Using the De Novo Pathway

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Global Medical Device Podcast

Common Mistakes That Can Tank Your 510(k) Submission

Episode 53

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Global Medical Device Podcast

How to Use Real-Word Evidence for Medical Device Regulatory Decisions

Episode 52

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eBook

Ultimate Guide to FDA Design Controls for Medical Device Companies

How to start using FDA design controls to your benefit today & implement a process to actual improve your medical device product development efforts.

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eBook

Ultimate Guide to Corrective and Preventive Action (CAPA) for Medical Devices

Learn how to implement and maintain a risk-based CAPA process while avoiding the most common pitfalls at your medical device company.

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Webinar

How Design Controls & Risk Management Best Practices Reduce Customer Complaints & CAPAs

This webinar covers common challenges with managing customer complaints and CAPAs, best practices for design controls and risk management, and how these practices will improve the ...

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Webinar

Best Practices for Medical Device Change Management

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How to Create a Risk-based CAPA Process

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Top 10 Most Significant Changes Introduced by the New EU MDR

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How to Prepare for the Medical Device Single Audit Program (MDSAP)

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Webinar

How QMS Software Can Speed Up Your Product Development & Simplify Compliance

Learn how modern, purpose-built software not only ensures you compliance with all the latest regulations but also frees up your engineers’ time, reduces risk, speeds time to ...

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Webinar

How to Prepare for a Successful Design Transfer

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How to Prepare for (and Make the Most of) Your FDA Pre-Submission

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Webinar

Many Connotations of Risk in Medical Device Development

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What You Need to Know About Life with FDA After Your Device Gains Clearance

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5 Things the Medical Device Industry Should Expect in 2017

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15 Steps to Get Approval to IEC 60601-1

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8 Steps to Implement an EU-MDR Compliance Program

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Webinar

How to Prepare for the New EU Medical Device Regulations (MDR)

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How to Simplify Your Compliance to the New ISO 13485:2016

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How to Prepare for the New EU In Vitro Diagnostics Regulations (IVDR)

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Webinar

510(k) Submission Tips, Tricks & Timlines from a Former FDA Reviewer

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Webinar

Medical Device Project Management Best Practices

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Webinar

Clinical Evaluation in the EU for Medical Devices

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Webinar

How To Avoid and Respond to FDA 483's and Warning Letters

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Everything Device Makers Need to Know About Design Controls

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Webinar

An Overview of ISO 14971 Risk Management

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Understanding the Changes to ISO 13485:2016

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How To Prepare for the Transition to ISO 13485:2016

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Global Medical Device Podcast

Lessons to Be Learned From Recent FDA Inspections

Episode 51

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Global Medical Device Podcast

Why the 510(k) Process Is So Stressful & How You Can Help Streamline It

Episode 50

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Global Medical Device Podcast

How Competitive Regulatory Strategy Differs from Regular Regulatory Strategy

Episode 49

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Global Medical Device Podcast

Comparing FDA Submission Types: 510(k) VS. De Novo VS. 513(G) VS. Pre-Submission

Episode 48

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Global Medical Device Podcast

How Process Excellence Leads to Product Excellence

Episode 47

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Global Medical Device Podcast

Understanding FDA’s Proposed Conformity Assessment Pilot Program

Episode 46

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Global Medical Device Podcast

Understanding the Difference Between a General Wellness Device and a Regulated Medical Device

Episode 45

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Global Medical Device Podcast

Understanding the Connection Between Complaints, CAPAs, and MDRs

Episode 44

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Global Medical Device Podcast

The Intersection of Medical Device Usability and Risk Management

Episode 42

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Global Medical Device Podcast

How FDA Interacts with Medical Devices When They Are Imported into the US

Episode 41

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Global Medical Device Podcast

How SimplicityMD Is Leveraging Technology to Help Get Their Devices to Market Faster

Episode 40

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Global Medical Device Podcast

An Overview of What Device Makers Need to Know About CAPA

Episode 39

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Global Medical Device Podcast

How Surgical Innovation Associates Found the Benefit of Quality Beyond Just Compliance

Episode 38

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Global Medical Device Podcast

Significant Risk vs. Nonsignificant Risk Devices - What's the Difference?

Episode 37

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Global Medical Device Podcast

What Devicemakers Need to Know About Medical Device Reporting (MDR)

Episode 36

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Global Medical Device Podcast

How Phagenesis Is Using Regulatory Affairs as They Develop a Treatment for Dysphagia

Episode 35

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Thought Leadership Article

3 tips for managing your medical device design history file

By Jon Speer, MedCity News

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Thought Leadership Article

4 Reasons Your 510(k) Submission Will Be Rejected (And How To Avoid Them)

By Jesseca Lyons, Med Device Online

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Thought Leadership Article

3 Tips to Reduce the Chance of a 510(k) Submission Rejection

By Jesseca Lyons, Medical Product Outsourcing

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Thought Leadership Article

Six Tips to Make Sure Your 510(k) Submission Is Accepted

By Jon Speer, Quality Digest

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Thought Leadership Article

6 tips to reduce likelihood of a rejection for an FDA 510(k) submission

By Jon Speer, MedCity News

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Thought Leadership Article

4 Tips for a Smooth 510(k) Submission Process

By Jon Speer, Medical Device and Diagnostics Industry

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Thought Leadership Article

ISO 14971 or FMEA: Which Should You Use?

By Jesseca Lyons, Quality Digest

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Thought Leadership Article

First-In-Human Studies - What's The Rush?

By Jon Speer, Med Device Online

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Thought Leadership Article

Debunking 4 commonly held design control myths

By Jon Speer, MedCity News

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Thought Leadership Article

Navigating the difficult road of medical device product development while avoiding the common pitfalls

By Jon Speer, MedCity News

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Thought Leadership Article

Eight Reasons Why Your Design Controls and Risk Management Processes Fail

By Jon Speer, Quality Digest

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Thought Leadership Article

Understanding ISO 14971 medical device risk management

By Jon Speer, MedCity News

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Thought Leadership Article

3 tips for applying risk management across medical device product development

By Jon Speer, MedCity News

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Thought Leadership Article

The Definitive Guide to Responding to FDA 483 and Warning Letters

By Jon Speer, Medical Design Technology

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Thought Leadership Article

What were the top reasons FDA issued device makers 483’s and warning letters in 2015

By Jon Speer, MedCity News

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Thought Leadership Article

8 Reasons Design Controls And Risk Management Processes Fail

By Jon Speer, Med Device Online

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Thought Leadership Article

How design controls apply to a 510(k)

By Jon Speer, MedCity News

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Thought Leadership Article

Get and stay on the FDA's good side with Jon Speer

Inspired Imua Podcast

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Thought Leadership Article

Why FMEA Is Not ISO 14971

By Jon Speer, Quality Digest

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Thought Leadership Article

Are Design Control Myths Holding Back Your Product Development?

By Jon Speer, Med Device Online

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Thought Leadership Article

A Step-by-Step Guide to Complying with Medical Device QMS Requirements

By Jon Speer, Medical Design Technology

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Thought Leadership Article

MedTech Blunders in Risk Management

By Jon Speer, MedTech Intelligence

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Thought Leadership Article

5 Tips to Help Your FDA 510(k) Submission (checklist included)

By Jon Speer, MedCity News

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Thought Leadership Article

Risk: Look at the Big Picture

By Jon Speer, MedTech Intelligence

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Thought Leadership Article

How to Prepare for an FDA Inspection

By Jon Speer, Quality Digest

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Thought Leadership Article

6 Development Steps To Fast-Track Your Medical Device's Path To Market

By Jon Speer, Med Device Online

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Thought Leadership Article

The Design Controls + Risk Management Connection: Using Design Reviews Effectively

By Jon Speer, Med Device Online

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Thought Leadership Article

An alarming device trend: Why getting 510(k) clearance alone is not enough

By Jon Speer, MedCity News

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Thought Leadership Article

7 Steps to Respond to FDA 483 Inspection Observations

By Jon Speer, MedTech Intelligence

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Thought Leadership Article

The Design Controls + Risk Management Connection — Verification, Validation & Risk Controls

By Jon Speer , Med Device Online

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Thought Leadership Article

The Importance of the Risk Management Plan

By Jon Speer, Medical Design Technology

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Thought Leadership Article

Design Controls & Risk Management: Two Sides of the Same Coin [Infographic]

By Jon Speer, MedCity News

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Thought Leadership Article

Risk Management: A Total Product Life-cycle Process [Infographic]

By Jon Speer, Legacy MEDSearch

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Thought Leadership Article

Risk Management for Medical Devices: An Introduction to the Process [Infographic]

By Jon Speer, MD+DI

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Thought Leadership Article

Risk management definitions you need to understand

By Jon Speer, Mass Device

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Thought Leadership Article

The beginner's guide to MedTech design verification and validation

By Jon Speer, MedCity News

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Thought Leadership Article

How to Avoid Exponentially Escalating Costs with Design Controls

By Jon Speer, MD+DI

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Thought Leadership Article

3 Tips for Incorporating Risk Management Throughout Medical Device Product Development

By Jon Speer, Medical Design Technology

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Thought Leadership Article

The Design Controls + Risk Management Connection — Intended Use & User Needs

By Jon Speer, Med Device Online

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Thought Leadership Article

5 tips to help you prepare for an FDA inspection

By Jon Speer, MedCity News

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Thought Leadership Article

4 Reasons Your Risk Management Approach is Wrong

By Jon Speer, MedTech Intelligence

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Thought Leadership Article

How to make FDA work for you – ATL Device Night

By Nick Tippmann, Mass Device

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Thought Leadership Article

The $400,000 FDA compliance mistake you don’t want to make

By Jon Speer, MedCity News

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Thought Leadership Article

5 Tips For Better Medical Device Risk Management

By Jon Speer, Med Device Online

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Thought Leadership Article

How to define medical device design inputs and outputs

By Jon Speer, MedCity News

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Thought Leadership Article

The Beginner's Guide to ISO 14971 Medical Device Risk Management

By Jon Speer, Medical Design Technology

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Thought Leadership Article

How medical device complaints can make you a better company

By Jon Speer, MedCity News

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Thought Leadership Article

Case Study: 5 Mistakes that lead to flushing $400,000 in fighting the FDA

By Jon Speer, OrthoStreams

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