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5 Elements that Must Connect to Your Design Controls for an Audit-Proof QMS

How to Set Up Clinical Studies to Comply with US FDA Regulations

The Essential Guide to eCRF (Electronic Case Report Form) for Medical Devices

Biocompatibility Testing for Medical Devices 101

Everything You Need to Know about Electronic Data Capture (EDC) for Clinical studies

IQ, OQ, PQ: A Quick Guide to Process Validation (Plus Free Resources)

Post-Market Surveillance for Medical Devices & IVDs: Requirements & Proactive Data Collection

ISO 13485 and FDA QSR: A Step-by-Step Guide to Complying with Medical Device QMS Requirements

Direct to Consumer - The Future of Healthcare

Medical Device Classifications - How To Determine Your Device Class

QMSR Explained: What FDA QSR & ISO 13485 Harmonization Means for Medical Device Companies

FDA De Novo Pathway: Process Explained for Medical Device Companies

Why Training Compliance Matters for Pre-Market MedTech Companies

Ultimate Internal Audit Checklist: FDA QSR & ISO 13485 Audit Checklist

Quality Management Plan - How to Create Yours (Tips & Best Practices)

How to Define Your Design Inputs and Design Outputs

How to Plan and Budget for MedTech Clinical Activities

MDCG Guidance Documents Overview on Clinical Investigations and Evaluations

Selecting The Ideal PMCF Activity

Clinical Data Collection - 7 Key Pitfalls To Avoid In MedTech

Top 100 Medical Device Companies (Free Chart Included)

FDA Form 483 Observations and FDA Warning Letters - What’s the Difference?

Bringing Medical Devices Into The Home

Get Compliant Clinical Data with Investigator-Initiated Studies

Making the BOM & Design Controls Connection

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

We Achieved ISO Certification! Now what?

[VIDEO] How to build a QMS using the best people, processes & technology (S.M.A.R.T Methodology)

EU MDR - 9 Top Questions Answered (European MDR)

Driving MedTech Innovation with Safe and Effective Medical Devices

Engineering Change Order: Its Role in the Change Management Process

What is a Quality Culture? (and 7 Tips for Creating One)

7 Tips for FDA 21 CFR Part 11 Compliance

How to Design an Electronic Case Report Form (eCRF) for Medical Device Studies

Electronic Data Capture Systems vs. Paper-based Data Collection

8 Tips Before Calculating Sample Size in Medical Device Clinical Studies

IVDR for In Vitro Diagnostic Medical Device Companies - Ultimate Guide

[VIDEO] 3 Easy Steps to Establishing a Quality & Regulatory Strategy for your Medical Device (Scope Phase)

How To Approach Supplier Corrective Action Requests (SCAR)

Sara Naab On Going From Idea to Funding to One of the Bay Area's Most Innovative Life Sciences Companies

Why the Conventional Wisdom Regarding ‘R’ and ‘D’ in Medtech Product Development Is Wrong with David Amor

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

How To Improve Your Design Reviews (Bonus Episode)

How to Properly Use the FDA Pre-Submission Process and Why It's So Important

How Phagenesis Is Developing a Treatment for Dysphagia with Rebecca Sheridan

Preparing Your Class II Device for the UDI Compliance Deadline with Reed Tech’s Gary Saner

Preparing for the Changes to the EU Medical Device and In-ViTRo Diagnostics Regulations

Using the Bucket Method for Medical Device Risk Management

Lessons to Be Learned from Recent FDA Inspections

Tips for Success When It Comes to IEC 60601 with Leo Eisner

Insider Tips and Best Practices Regarding the 510(k) Submission Process with Allison Komiyama, a Former FDA Reviewer

Risk Management from a Regulatory & Product Development Perspective [Podcast]

How To Identify, Quantify and Manage Enterprise Risks for Medical Device Companies with Mike Cremeans

How SimplicityMD Is Leveraging Technology Plus a Lean Approach to Help Get Their Devices to Market Faster

An Insider’s Look at the Changes Coming in ISO 13485:2016 with Mark Swanson, a Member of the Standard's Working Group

What Substantial Equivalence Means as It Applies to 510(k)'s & Why It's Important

Understanding the New FDA Guidance on Changes to a 510(k)

How Competitive Regulatory Strategy Differs from Regular Regulatory Strategy (And How to Use It to Your Advantage)

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

Tips for Avoiding Problems with the First-In-Human Study Process

How To Avoid Major Common Mistakes During the FDA 510(k) Process with Michael Drues

Helping to Prepare Biomedical Engineers Entering the Workforce

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

Enabling MedTech Innovation through Cross-functionality

The New Special 510(k): What You Need To Know

Meet a Guru: Jesseca Lyons

Why Supplier Quality Management Is So Important

Latest Updates on CDRH Standards Program and IEC 60601

What you need to know About FDA’s Progressive Programs

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

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

MDSAP Approach - Navigating the Medical Device Single Audit Program

Implementing an eQMS after Switching from Paper

5 Dos and Don'ts when Choosing a QMS Solution for Your Medical Device Company

A Free CAPA Template for the Medical Device Industry

[VIDEO] How to Calculate the Cost Of Quality: Building the Business Case for your Medical Device QMS

Medical Device Companies - Top 100 in 2020 (Free Chart) (Clone)

Greenlight Guru and EMERGO by UL Announce Strategic Alliance to Simplify and Automate Global Market Access for Medical Device Companies

From Closed to Connected: Share Data & Unlock Efficiencies with Greenlight Guru’s Export API

15 Steps to Getting Approval for IEC 60601-1 (Staging)

Medical Device Risk – ISO 14971 Gets It Right

[VIDEO] Integrating Design Controls & Risk Management To Streamline Product Development (Make Phase)

Clinical Evaluation Reports — Things You Should Know About the MEDDEV 2.7/1 Revision 4

How Sonavex Went from Concept to FDA Clearance in Just 3 Years

COVID-19 Impact on Medical Device Industry: How to Navigate the Chaos and Support Public Health

[VIDEO] How to Prepare your QMS for a Successful Medical Device Product Launch (Release Phase)

[VIDEO] 4 Medical Device Manufacturing Best Practices for a Successful Design Transfer (Approve Phase)

[VIDEO] 7 Ways to Track QMS Effectiveness using Medical Device Post-market Quality Processes (Track Phase)

Data Management and Reporting in FDA-Regulated Clinical Trials

How 4 Pre-Market MedTech Companies are Leveraging Greenlight Guru Quality

Preparing a Successful FDA Medical Device Submission

Checklist/Template

Complaint Log + Form Template Bundle

Greenlight Guru Clinical & BSI Life Sciences: Live Demo Integration

Maximizing Value from Design Controls: Strategies for Medical Device Companies

EU MDR Hot Takes: Evolution or Overreach?

Integrating Clinical Strategy and Project Management for Cost-Effective Clinical Investigations

Who Owns the Design Controls Process?

Live with FDA: Accelerating a Quality Culture at Your Medical Device Company

Checklist/Template

Verification Protocol Template

Designing a Medical Device for a Global User

2024 MedTech Path to Market True Quality Summit Series

FDA's Proposed Wound Dressing Rule: Industry Impacts & Regulatory Insights

Global UDI Updates: Navigating EUDAMED Changes & Health Authority Trends

Medical Device Biocompatibility 101

A Guide to Bridging User Needs Into Design Requirements

Step-by-step Guide to Complying with ISO 13485 & FDA QSR

QMSR (Quality Management System Regulation) Explained: What FDA QSR & ISO 13485 Harmonization Means for Medical Device Companies

Checklist/Template

Content Toolkit for Medical Device Product Developers

MDR and IVDR: Challenges and Opportunities of the New Regulations

Clinical Evidence: The Key to Market Adoption

Paper Systems Are the Riskiest Way to Manage Medical Device Projects

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

From LDTs to IVDs: Navigating the New Regulatory Landscape

LDT Enforcement Discretion Phaseout: What You Need to Do in the First Year

2024 Greenlight Guru True Quality Roadshow: Copenhagen Recap

Creative Clinical Recruitment

How to Define and Decode Your Design Inputs and Design Outputs

Why FMEA is Not ISO 14971 Risk Management

FDA Issues LDT Final Rule to Regulate Laboratory Developed Tests as IVD Devices

How to Carry Out PMCF Activities According to EU MDR

Getting Hired In MedTech

Strategies for Navigating the EU MDR Extension Deadlines

Achieving ISO 13485 Certification

QMSR & the End of DMR, DHR, DHF: How FDA’s New Rule Impacts Record-Keeping

Checklist/Template

FDA Pre-Submission Meeting Checklist for Medical Device Companies

Meet a Guru: Jamie Bihary

FDA’s PMA Supplements and Amendments: When and How to Use Each

Advice to Medical Device Inventors

Design History File (DHF) vs. Device Master Record (DMR) vs. Device History Record (DHR): What's the Difference?

IQ, OQ, PQ: A Quick Guide to Process Validation

Obtaining Institutional Review Board (IRB) Approval

MDCG 2024-5: Guidance on the Investigator’s Brochure Explained

Interviewing the Interviewer

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

Beginner's Guide to Design Verification & Design Validation for Medical Devices

Ultimate Guide to Device Class Requirements under EU MDR

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

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

Checklist/Template

GSPR Template

Checklist/Template

Medical Devices Essential Principles Checklist

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

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

Entering the Australia & New Zealand Markets: What Medical Device Manufacturers Need to Know

Checklist/Template

MDSAP QMS Audit Checklist

QMS Principles for Software As a Medical Device (SaMD) Manufacturers

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

How are Medical Devices Classified under EU MDR?

ISO 14971 Risk Management for Medical Devices: The Definitive Guide

MDCG 2024-3: What the Latest Guidance on Clinical Investigation Plans (CIP) Tells Us

Checklist/Template

Clinical Investigation Plan (CIP) Synopsis Template

Building a Partnership with your Regulatory Consultant

Bringing a Self-Funded Medical Device to Market

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

Checklist/Template

Resource Bundle for Risk Managers

Managing Risk in Clinical Investigations

Definitive Guide to Change Management for Medical Devices

Speaking the Language of IVD

Revolutionizing Medical Device Trials with Risk-Based Monitoring

Checklist/Template

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

Ultimate Guide to Clinical Data Management in MedTech

Top 50 Medical Device Product Design and Development Companies

Ultimate Guide to Clinical Data Management in MedTech

Is It Possible to "Buy" a QMS?

Mastering Document and Change Management with Greenlight Guru Quality

Designing Effective PMCF Surveys in Greenlight Guru Clinical

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

What is a Class III Medical Device in the US?

FDA 510(k) Submission: A Step-By-Step Guide On How To Prepare Yours

Improving Study Management in MedTech with Greenlight Guru Clinical’s Custom Collaborator Roles

Greenlight Guru Shines in G2 Spring 2024 Report, Dominating in Medical QMS and EDC Categories

Project Management in MedTech

Meeting Timelines and Managing Budgets - Best Practices for MedTech Clinical Investigations

Live Q&A with FDA: Cybersecurity Premarket Guidance

Step-by-Step Guide to FDA PMA Submissions for Class III Medical Devices

Ultimate Guide to ISO 13485 for Medical Devices QMS

Checklist/Template

Premarket Approval Inspection Checklist

Key Expectations for ISO 14971 Compliance with Implementation of QMSR

How to Take Control of Training Management and Stay Compliant with ISO 13485:2016 and Part 820.25

Ready to Submit Your FDA 510(k)? But Wait, There's No Human Factors!

Checklist/Template

MDSAP vs. ISO 13485:2016 Gap Assessment Tool

FDA's Voluntary Improvement Program

QMSR Final Rule: Meeting FDA’s New Requirements

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

Leveraging Automated Training with Greenlight Guru Quality

How to Create a Quality Management Plan

The State of UDI Across the World

eSTAR 5.0: Are You Ready?

Adopting AI in Quality Management: Practical Solutions for the MedTech Industry

How to Structure your Medical Device Technical File

Outsourcing Clinical Activities in 2024: Choosing A CRO

Quality Assurance vs. Quality Control in the Medical Device Industry

ALM and Design Controls: Do SaMD and SiMD Manufacturers Need Both?

Investigator Initiated Studies — 3 Common Problems and How to Fix Them

How MHRA is Regulating Medical Devices in the UK after Brexit

Quality Myths & Lessons Learned Part II

5 Habits of Highly Effective MedTech Companies

Mastering the Pitch: MedTech Innovations from Concept to Market

2024 State of the MedTech Industry True Quality Summit Series

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

How to Use the Turtle Diagram for Better Internal Audits

Greenlight Guru Announces the 2024 True Quality Roadshow

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

Key Pitfalls to Avoid in MedTech Clinical Data Collection

Becoming a MedTech Regulatory Affairs Professional

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

Calculating Nonconformance Costs in the MedTech Industry

FDA Publishes Final Rule on QMSR

Introducing Risk Reviews for Efficient, Compliant Risk Management

Top Medical Device Conferences To Attend in 2024

Checklist/Template

FDA QMSR & ISO 13485:2016 QMS Internal Audit Checklist

Checklist/Template

Cybersecurity Gap Assessment Checklist

Selecting a Notified Body: How to Work with Your New Device Authority

Key Elements to Outsourcing Clinical Activities in 2024

How Artificial Intelligence is Impacting the MedTech Industry

UDI Product Data and EUDAMED, Get Onboard!

2024 Revealed: Discover What’s New and What’s Next for Greenlight Guru

Greenlight Guru Finishes 2023 with Strong Momentum in Q4

Medical Device Clinical Trials: Regulatory Pathways & Study Types Explained

IVDR: How to Meet the Quality Management System Requirements of a Device

Fundamentals of Quality & Regulatory

Achieving Real-Time Audit Readiness Using Greenlight Guru Quality

Integrating eCRF and ePRO in One Single Platform

Navigating Clinical Evaluations and Investigations in MedTech

The State of AI & Clinical Investigations

Demystifying FDA’s Pre-Market Final Guidance

How PLM and QMS Solutions Work Together in MedTech

The Evolving Landscape of AI in MedTech

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

Checklist/Template

Align Your Clinical Claims Webinar Q&A

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

Greenlight Guru’s MedTech Suite Named a Leader in G2 Winter 2024 Grid Report

Greenlight Guru Clinical: Leader in the EDC Category in G2 Winter 2024 Grid Report

Customers Rank Greenlight Guru Quality as Medical QMS Leader in G2 Winter 2024 Report

Most Popular Medical Device Content in 2023

Considerations for IVD

Moving MedTech Forward: Greenlight Guru’s 2023 in Review

Maximizing Clinician Participation in Post-Market Operations

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

Top 40+ Medical Device Contract Research Organizations (CROs)

Human-Centered Design in Medical Devices

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

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

FDA's eSTAR Program

Mastering Medical Device Audits: A Proven Formula

AI, Automation, and Risk in MedTech

Checklist/Template

ChatGPT Sample Prompts for Risk Evaluation of a Medical Device

A Better Way to Develop a Medical Device with Digital and Physical Elements (Part 1 of 2)

A Better Way to Develop A Medical Device with Digital and Physical Elements (Part 2 of 2)

Best Practices for Patient Recruitment in MedTech Clinical Studies

Using AI in MedTech

The Ugly Truth About Managing Design Controls on Spreadsheets

Checklist/Template

Training Matrix Template

Becoming an Advisor to a Medical Device Company

How Quality & Regulatory Compliance Drive Financial Performance in MedTech

Enterprise Quality Management Software: What You Need To Know

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

Recent FDA Draft Guidances

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

Ultimate Guide to Supplier Management for Medical Device Companies

The AI in MedTech Trend Report 2023 Is Here

Greenlight Guru Releases The AI in MedTech Trend Report 2023

How to Boost Patient Recruitment in Greenlight Guru Clinical

CAPA Process: Step-by-Step Instructions [+ Free Infographic]

AI in MedTech Trend Report 2023

Benefits of Switching from MasterControl to Greenlight Guru

Planning an FDA Submission

Reducing Medical Device Risk with Usability Testing: The Why, the How, and the Who

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

Ultimate Guide to Software as a Medical Device (SaMD)

Top 7 QMS Tools for MedTech (Plus 4 Bonus Resources)

What NOT to say to FDA

The Ultimate Internal Audit Checklist Every Medical Device Company Needs

Greenlight Guru Expands Market Leadership with Strong Momentum in Q3 2023

Ultimate Guide to IVDR for In Vitro Diagnostic Medical Device Companies

5 Foundational Steps of a CAPA Quality Process

Understanding LDTs & the FDA Proposed Ruling

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

9 Questions About the European MDR Answered

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

Live eCRF Setup and Forms Building in Greenlight Guru Clinical

FDA Proposes New Rule to Regulate LDTs as IVDs: Here’s What’s at Stake

UDI and EUDAMED: Past, Present and Future State

MHRA Guidance Document on Clinical Investigations in UK

Data Management and Monitoring in MedTech Clinical Studies

Guide to Understanding AI Applications that Drive Business Value in MedTech

Selecting a Site for Your Clinical Trial

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

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

Greenlight Guru Celebrates 10 Years by Introducing its Multi-Product MedTech Suite

Introducing The Greenlight Guru MedTech Suite: A Comprehensive Set Of Industry-Specific Solutions

How to Approach Corrective Action Requests with Medical Device Suppliers

ISO 14155:2020 Compliant Clinical Investigations - The Ultimate Guide

Ultimate Guide to ISO 14155:2020 for Medical Devices

Engineering Change Order: The Role it Plays in the Change Management Process

5 Tips for Medical Device Registration across Global Markets

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

Greenlight Guru Yet Again Ranked as a Leader in QMS and Medical QMS Categories in G2 Fall 2023 Grid Reports

How to Structure a Clinical Investigation Report (CIR) Summary

Checklist/Template

How to Clear a Software Medical Device

Accelerating SaMD Development in a Compliant Agile Way

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

Creating a Supplier Scorecard for Medical Device Supplier Management

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

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

What is a Predetermined Change Control Plan (PCCP) and Who Needs One?

MedTech Funding and Preparing for Due Diligence

3 Tips for Adding Flexibility to Your MedTech Manufacturing Supply Chain

Exploring Breakthrough Device Designation

Global MedTech Regulatory Trends: True Quality Summit Series

What is the FDA Medical Device Registration Process?

Machine Learning, AI and Risk Management: TIR34971 Explained

How to Comply with HIPAA and EU GDPR in Medical Device Studies

Regulatory Strategy and the Advantage of Diversity in MedTech

Preparing Your Technical Documentation under MDR: Proven Tips & Techniques

Greenlight Guru Invests in State-of-the-Art Arena and Training Facility That Aims to Help Youth Basketball Players On and Off the Court

Conducting Quality Investigations in Medical Device Manufacturing

28 Days To Save The World - True Quality Roadshow

Omnibus Act Impact on Medical Device Cybersecurity

Boost Efficiency and Decision-Making with Enhanced Clinical Data Reporting

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

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

Checklist/Template

Validation Toolkit

Developing IEC 62304 Compliant Software: Proven Tips & Best Practices

FDA Guidance on Artificial Intelligence (AI) in Medical Devices

Greenlight Guru Continues Strong Growth in Q2 2023 Powered by Product Innovation

2023 Risk Management True Quality Summit Series

How to Improve Detecting, Correcting, and Preventing Nonconformances

Ultimate List of ISO Standards for Medical Devices

The Role of dFMEA in Risk Management for Medical Devices

Checklist/Template

Class 1 Medical Device Content Bundle

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Class 2 Medical Device Content Bundle

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Class 3 Medical Device Content Bundle

Understanding the ROI of an eQMS

CSA vs. CSV: Modern Validation for Modern MedTech

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

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

Identifying and Evaluating Medical Device Importers

Writing a Clinical Investigation Plan (CIP): The Essential Guide

Management Responsibility: The most important part of a QMS

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

How to Design the Optimal eCRF for Clinical Investigations

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

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

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

How to Develop a Risk-Based Approach to Supplier Management

Customers Rank Greenlight Guru Leader in QMS and Medical QMS Software in G2 Grid Reports for Summer 2023

Alternatives to PMCF Clinical Investigations

The Combination Products Handbook

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

Checklist/Template

Clinical Evaluation Toolkit

15 Reasons Why Medical Device Companies Choose Greenlight Guru

How to Manage Complex Downstream Design Changes to Your Medical Device

Purpose-Built QMS vs General-Purpose QMS: What You Can Expect From Each

Understanding the ROI of an eQMS Solution

Leaning into Lean Documentation

Greenlight Guru Publishes Independent Study Showing the ROI of eQMS Solutions on MedTech Companies

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

How to Plan and Budget for MedTech Clinical Activities

Checklist/Template

MDR & IVDR Gap Analysis Toolkit

CSV vs. CSA: Exploring FDA’s New Software Validation Approach

Making the Business Case for an eQMS Solution for Your Company

Cybersecurity and the Future of MedTech

Greenlight Guru Modernizes Validation Approach to Streamline Software Implementation and Adoption for Medical Device Companies

Checklist/Template

Budgeting for MedTech Clinical Activities Checklist

Pre-Market Medical Device Studies and GCP - Strategies for Success

Managing Major Changes to Medical Device Packaging

What is a Modern QMS?

5 Tips for Designing a Medical Device Study Under FDA Requirements

Implementing Risk Throughout the Entire Product Lifecycle

4 Tips for Managing Your MedTech Portfolio

How To Use FDA’s Guidance on Post-Approval Studies During Premarket Approval

2023 Greenlight Guru True Quality Roadshow: San Jose Recap

Putting Together the Pieces for Success with Greenlight Guru

Ad Promo and The Difference in Regulatory & Legal

Checklist/Template

Checklist for Protecting your IP throughout the MedTech Lifecycle

How AI Can Help You Manage Risk

How To Vet Medical Device Distributors in Multiple Markets

Checklist/Template

What to Include in Your Quality Assurance Agreement with a Distributor

What is the Best Way to Structure a Risk Management File?

7 Tips to Comply With FDA 21 CFR Part 11

The Tools that Make Clinical Investigations

eIFU Requirements: Everything You Need to Know About Electronic Instructions for Use

Understanding ISO 14971 Medical Device Risk Management

Oticon Medical Continues Striving for Clinical Excellence

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

5 Dos and Don'ts when Choosing a QMS Solution for your Medical Device Company

Introducing Risk Solutions: A New Era in Risk Management for MedTech

Greenlight Guru Launches AI-Powered Solutions to Enable Better Risk Management for the MedTech Industry

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

How to use the Greenlight Guru Clinical AE/SAE reporting module

To Commercialization & Beyond True Quality Summit Series

Planning Your Medical Device Global Market Regulatory Strategy

How To Gain Better Access to Healthcare Decision Makers

Complaint Handling with Medical Device Guru, Brittney McIver

Why Clinical Data Is Essential to Value-Based Healthcare

3 Things to Love about Internal Audits

HTEC Group Partners with Greenlight Guru to Accelerate Time-to-Market for Medical Device Companies

Avoiding Potential Issues with your 510(k) Submission

How to Show ROI on Your Clinical Evidence

4 Advantages of an eQMS Over a Paper-Based QMS

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

Monarch Medical Makes Sense of Document Management With Greenlight Guru Quality

Meet a Guru: Brittani Smith

Greenlight Guru Builds Strong Momentum in Q1 2023 as Medical Device Companies Move to Modern Digital Solutions

4 Reasons to Stop Mixing Your Clinical Data Collection Methods

How To Avoid a Failed QMS Implementation

5 Steps for Getting your CE Marking with EU MDR Requirements

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QMS Implementation Checklist Template

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Quality Management System (QMS) Software Vendor Checklist

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

2023 Greenlight Guru True Quality Roadshow: Houston Recap

Why Building Supplier Relationships Is So Important

Post-Market Clinical Follow-up Under EU MDR: Guide to PMCF Activities

Can dFMEA and ISO 14971 Co-Exist in Medical Device Risk Management?

“A Perfect eQMS”: Customers Rank Greenlight Guru #1 QMS in G2 Spring 2023 QMS Grid Report

ePRO vs Paper: The Debate Over Patient Reported Outcomes Is Over

Systematic Literature Review for EU MDR

Greenlight Guru Introduces Export API for a Connected Quality Management System

From Closed to Connected: Share Data & Unlock Efficiencies with Greenlight Guru’s Export API

eBOM vs mBOM: What’s the Difference?

Medical Device Adverse Event Reporting Regulations: EU vs. US

5 Tips for Running Effective Internal Quality Audits

Building Your Design Controls (and Pitfalls to Avoid)

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

Checklist/Template

ISO 14971:2019 Gap Analysis Tool

How to Handle Medical Device Adverse Events

Electronic Data Capture Systems vs. Paper-based data collection

Explaining IVDR Classification for In Vitro Medical Devices

Most Common Problems Found During FDA Inspections in 2022

MDR Compliant Prospective & Retrospective Clinical Studies

Complete Guide to Bringing a Medical Device to Market

Making the BOM and Design Controls Connection

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

The Ultimate Guide To Design Controls For Medical Device Companies

Clinical Data Management System (CDMS) for Medical Device Clinical Trials

Everything You Need to Know about Electronic Data Capture (EDC) Systems

10 Best Practices for eCRF in Medical Device Trials

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

Going from Weeks to Hours of Audit Prep Time for Easy ISO 13485 Certification

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15-in-1 MedTech Template Bundle

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

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General Safety and Performance Requirements (GSPR) Gap Assessment

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Top 30 MDCG Guidance Documents for Medical Device Companies

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Top 40 IMDRF Technical Documents for Medical Devices

Complying with Good Clinical Practice in Clinical Data Collection

Understanding the 'Compliance Manager' Role

Medical Device Classification Guide - How To Determine Your Device Class

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MDD vs. MDR Gap Assessment Tool

How to Define User Needs During Design Controls

Research shows eCRFs faster, more reliable than paper CRFs

21 CFR Part 11: A Complete Guide

Greenlight Guru Introduces Newly Expanded Global Partner Program

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

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

Does My Device Labeling Comply with 21 CFR 801?

Utility Patent vs Design Patent: Choosing the Right One for Your Device

How to Switch from Paper to EDC Systems in Your Next Clinical Study

Ultimate Guide to Postmarket Surveillance of Medical Devices

7 Essential Steps of a Nonconformance Report

How to Choose an Electronic Data Capture System to Comply with EU MDR

Checklist/Template

Checklist for Clinical Data Collection and Efficient Study Setup

Switching to an Electronic Device History Record (eDHR): What Medical Device Companies Should Know

What is a Class 1 Medical Device?

How Communication Affects the Outcomes of Quality Activities

FDA Human Factors Guidance Draft: What Medical Device Manufacturers Need to Know

3 Factors that Impact Application of Decentralized Clinical Investigations for Medical Devices

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Checklist to Evaluate Your Quality Control Process

Checklist/Template

5 Tips for IEC 60601 Submissions

Top 100 Medical Device Companies in the World (Free Chart Included)

HEMEX Leverages Greenlight Guru Clinical to Help Clients Collect High-Quality Clinical Data More Efficiently

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

Brain Healthcare Innovator Firefly Neuroscience Uses Greenlight Guru Clinical

Part 2: The Theranos Loophole & Lab Developed Tests

5 Processes You Need to Invest In to Bring a Device to Market

How Electronic Data Capture is Transforming the MedTech Industry

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

What is a Document Control System?

Part 1: The Theranos Loophole & Lab Developed Tests

MDR by the Numbers: Leveraging New Data for Implementation Planning

The Pitfalls of Using Paper and Excel for Clinical Data

eConsent in Clinical Trials for MedTech: How to do it Efficiently

Tips for Ensuring Your Clinical Data Complies with FDA's 21 CFR Part 11

Applying ISO 10993-1 to Medical Device Submission to FDA

Checklist/Template

21 CFR Part 11 compliance checklist for clinical records and e-signatures

What is a Class 2 Medical Device in the US?

Process Verification vs Process Validation: What’s the Difference?

Top Risk Management Tools in the Medical Device Industry

Best Practices for eConsent in Medical Device Clinical Investigations

Creating a Periodic Safety Update Report (PSUR) that Complies with MDR & IVDR

FDA Form 483 Observations and Warning Letters - What’s the Difference?

What is 21 CFR 812 - Investigational Device Exemption?

Greenlight Guru Announces 2023 True Quality Roadshow

Implementing an eQMS after switching from Paper

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

2023 State of Medical Device True Quality Summit Series

Greenlight Guru Releases 2023 MedTech Industry Benchmark Report

Computer Systems Validation: How To Avoid FDA Warning Letters C.F.R. 820.70(i)

How to Collect PMCF Data for Lower-Class Medical Devices and WETs

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

What is a Traceability Matrix and How Do I Create One for My Medical Device?

2021 EU MDR Preparedness Study

Building a Startup in the MedTech Industry

Greenlight Guru Launches Greenlight Guru Academy as a Trusted Source of Education to the Global Medical Device Community

Case Study: How Flexlogical Is Making Quality A Competitive Advantage By Adopting A Data-driven Approach With their Quality System

Meet a Guru: Karen Schuyler

How to Demonstrate Substantial Equivalence in 5 Easy Steps

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

Everything you Need to Know about SaMD from an FDA Perspective

How to Use Voluntary Consensus Standards to your Strategic Advantage

Preparing for Remote and On-Site Inspections and Audits

How does EU MDR impact your Quality Management System?

Special 510(k) vs. Abbreviated 510(k) vs. Traditional 510(k): Which FDA Program Applies to My Device?

Virtual Auditing in a Post-COVID World of Digital Compliance

Case Study: How Delta Development Fast-tracked R&D Down to 1 Year by Implementing a Medical Device QMS

5 Ways to Leverage Internal Quality Audits to Improve External Audit Outcomes

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

Greenlight Guru Announces True Quality Summit Series: EU MDR & IVDR

Ultimate Guide to Training Management for Medical Device Companies

Prioritizing Medical Device Reimbursement During Product Development

Understanding ISO 13485 Training and Competency Requirements

5 Key Principles of Total Quality Management

5 Actionable Lessons Learned from the RADx Initiative by NIH

How Does a Medical Device Quality Management System Differ from other QMS Tools?

2021 State of Medical Device Virtual Summit

Submitting a 510(k)? First Make Sure You Know What 'Substantial Equivalence' Means

How a Partnership with Greenlight Guru Helped Rook Quality Systems Grow 15X in SIX Years

What are the Strategic Priorities for CDRH in 2021?

Change Management Process Explained in 6 Easy Steps (+ free template)

Understanding and Handling Different Types of Feedback

How to Use the De Novo Pathway for your Medical Device

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

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

Greenlight Guru and Nelson Labs Announce Strategic Alliance to Mitigate Risk and Guide Customers to Market Faster

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

Most Popular Medical Device Content in 2020 from Greenlight Guru

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

6 Benefits of the Best 21 CFR Part 11 Compliant Software

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

2021 State of Medical Device Quality Management and Product Development Benchmark Report

Why SaMD Companies Should be Leveraging Pre-Submissions to FDA

What is the True Cost of Poor Quality for Your Medical Device Company? (Free Infographic)

12 Medical Device Experts Offer Best Tips for How to Succeed in 2021

What Goes into Designing Devices for Military and Emergency Applications?

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

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

Streamline the right training, for the right people, at the right time. Introducing Greenlight Guru Training Management

Greenlight Guru Introduces Training Management to Simplify Regulatory Compliance and Streamline the Employee Training Process

3 Powerful Ways to Revolutionize your Approach to Closed-Loop Quality System Traceability

Positive and Negative Impacts of EUA on the Medical Device Industry

Developing Pediatric Medical Devices: An Innovative Approach

Greenlight Guru Announces The 2021 State of Medical Device Virtual Summit

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

Why Biocompatibility Should be Addressed by Every Medical Device Company

Everything You Need to Know about Human Factors Engineering for Your Medical Device

Checklist/Template

Content Toolkit for Medical Device Startups

Meet a Guru: Erica Loring

Free Complaint Template for Medical Devices

Free Template: Nonconformance Process for your Medical Device

Greenlight Guru Introduces Quality Event Automation to Advance Efficiencies in the Management of Post-Market Quality Events

CAPA Template

23 Must-haves for your Product Requirements Document (Free Checklist + Guide)

What is a Multiple Function Device?

3 Reasons Why Closed-Loop Traceability is a QMS Must

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

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

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

519 Medical Device Manufacturers Reveal Biggest Barriers to Process Improvement

How Jon Speer Met His Most Frequent Guest: Mike Drues

Document Control for Medical Device Companies: The Ultimate Guide

Meet a Guru: Wade Schroeder

Unannounced Audits: A Survival Guide for Quality Managers

What are the Audit Etiquette Rules I Should be Following?

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

Meet a Guru: Tom Rish

How Do I Determine if my Product is a Medical Device?

Addressing Clinical Trial Challenges & Concerns during COVID-19

What is FDA's Approach to Regulating AI/ML in Software as a Medical Device?

Protecting the Intellectual Property of your Medical Device Technology

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

Top 100 Medical Device Acronyms & Terminology You Need to Know

Meet a GURU: Jesseca Lyons

How to Escape the Lure of Legacy Quality Management Systems

How to Build a QMS for a Medical Device

Medical Device Reporting (MDR): How to Take Advantage of Your Electronic Records

Meet a Guru: Taylor Brown

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

How to Plan and Control the Design of your Medical Device while Meeting Regulatory Expectations

What is Regulatory Due Diligence for Medical Devices?

How to Validate Cloud-based Software Tools

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

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

How to Construct an Effective Regulatory Strategy

22 MedTech Experts Share Best Tips for Product Developers, QA/RA Professionals & Leadership Roles

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

EUA 101: What is Emergency Use Authorization and How can my Device get Authorized?

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

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

EU MDR Delay: How to Plan Beyond the Coronavirus Pandemic

How COVID-19 is Impacting the Medical Device Industry: Data, Benchmarks & Trends

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

Greenlight Guru and EMERGO by UL Announce Strategic Alliance

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

Documentation Priority for Early Stage Medtechs — Part 1: User Specification

How to Approach Verification and Validation for Cloud Software

What are the Changes to ISO 14971:2019 & TR 24971?

How Software Architecture Enables Faster Release of New Clinical Tests to the Market

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

How can Medical Device Companies use the Emergency Use Authorization (EUA) to Address the COVID-19 Pandemic?

3 Ways Medical Device Companies Working Remote are Leveraging QMS Software to Foster Innovation and Collaboration

COVID-19 Impact on Medical Device Industry: How to Navigate the Chaos and Support Public Health

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

How to Integrate Usability into your Medical Device

How to Estimate Sample Size for Medical Device Clinical Studies

4 Emerging Trends in 2020 Backed by Medical Device Industry Experts

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

Only 6% of Device Makers Are Ready for EU MDR — Are You? Here are 3 Ways to Transition Now

How to Leverage IEC 62304 to improve SaMD Development Processes

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

Greenlight Guru Updates Risk Management Capabilities to Align with ISO 14971:2019, Further Enhances Change Management Capabilities

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

How to Choose the Right FDA Regulatory Pathway for your Device

How to Use UX to Streamline Medical Device Product Cycles

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

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

7 FDA Pathways to Bring Your Medical Device to Market

[VIDEO] 3 Easy Steps to Establishing a Quality & Regulatory Strategy for your Medical Device (Scope Phase)

[VIDEO] 7 Ways to Track QMS Effectiveness using Medical Device Post-market Quality Processes (Track Phase)

[VIDEO] How to build a medical device QMS using the best people, processes & technology (S.M.A.R.T Methodology)

[VIDEO] How to Calculate the Cost Of Quality: Building the Business Case for your Medical Device QMS

[VIDEO] How to Prepare your QMS for a Successful Medical Device Product Launch (Release Phase)

[VIDEO] 4 Medical Device Manufacturing Best Practices for a Successful Design Transfer (Approve Phase)

[VIDEO] Integrating Design Controls & Risk Management To Streamline Product Development (Make Phase)

4 Parts to Interviewing Candidates for Medical Device Roles

Understanding Post-Market Surveillance Requirements for Medical Devices (US & EU Markets)

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

4 Major Reasons to Use Document Version Control Software for your Medical Device

The Art of Defining Design Inputs And Design Outputs

Navigating the Twists and Turns of Change Management for Medical Devices

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

What is FDA's ASCA Pilot Program and How Does it Impact Medical Device Manufacturers?

Understanding FDA’s Proposed Conformity Assessment Pilot Program

3 Pros and Cons to 3D Printing for Medical Devices

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

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

Greenlight Guru Announces Enhanced Change Management Capabilities

How to Solve the Medtech Value Equation with Quality Data

FDA 21 CFR Part 820: 8 Most Common Mistakes to Avoid

Checklist/Template

IVDR Gap Assessment Tool

Why Supplier Quality Management Is So Important For Medical Device Companies

State of Medical Device Product Development and Quality Management Report 2020

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

Preparing for EU MDR

Tips for Success with IEC 60601 for Electrical Medical Devices

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

EU MDR Implementation Guide

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

Passing MDSAP Audit & Getting FDA Approval Just Weeks After Implementing Greenlight Guru Quality

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

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?

Improving Outcomes and Reducing Costs with an Intelligent Surgical Medical Device

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

Checklist/Template

Content Toolkit for Medical Device Executive Leaders

4 Biggest Challenges in Medical Device Manufacturing (and how to overcome them)

Leveraging Technology and Rapid Prototyping Methodologies during Product Development

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

Best Practices for Expediting Your Product Development

Why Design Verification Matters in Medical Device Design and Development

5 Tips from MedTech Executives on the Value of Quality

Checklist/Template

Content Toolkit for Medical Device QA/RA Professionals

Implementing Changes to SaMD under New EU MDR

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

Why the FDA Pre-Submission is an Underutilized Tool

Right-sizing your QMS

How and When to Register EU Medical Devices and Report UDI Information to EUDAMED

How to Evaluate a Company’s Regulatory and Quality ‘Health’ Before Investing

Challenges with Pediatric Medical Devices

13 Tips For Audit Etiquette Every Medical Device Company Should Know

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

How to Apply Risk Management Throughout the Product Lifecycle of your Medical Device

When Should You Start a QMS?

Ultimate Guide to Agile Design and Development for Medical Devices

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

A Firsthand Account of the Origins and Outcomes of FDA's Case For Quality and MDDAP

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

10 Steps to Preparing Your 510(k) Submission (And How to Avoid the Common Pitfalls)

6 Most Common Mistakes When Implementing ISO 13485

Importance of Software Requirements in Product Development

How to Perform Effective Root Cause Analysis

Eliminating Subjectivity and Guesswork with a Modernized Solution to Detecting Ear Infections

Checklist/Template

EU MDR Economic Operators Guidance Document

4 Facts That May Surprise You About FDA

Should you Swipe Right or Left on your Notified Body?

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

Breakthrough Designation Program: Is this an option for my medical device?

Why I Used To Hate Risk Management (And 3 Ways to Change Your Mind Too)

Checklist/Template

EU MDR: SaMD Guidance Document + Audit Gap Assessment Tool

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

Creating a Culture of Quality for Medical Device Companies

Challenges with MedTech Innovation

FDA QSIT: Preparing Your Medical Device Company for an Inspection

Is Your Medical Device Company CAPA Happy?

Quality Leaders' Playbook for Driving Executive Engagement with Quality Systems

10 Essentials for Writing a Clear Product Requirements Document [Guide+Checklist]

Integrating Human Factors into Design Controls to Improve Patient Outcomes

5 Most Common Mistakes Made When Implementing ISO 14971

Greenlight Guru In the Classroom: A University's Real-world Approach

The Essential Guide to Preparing your QMS for EU MDR

Improving the Colon Cancer Screening Experience

EU MDR: Not All Doom and Gloom

Why Design Validation is More Than Testing: How do we validate our validation?

Qualifying Your Suppliers Using a Risk-based Approach

Biocompatibility Nuances and its Impact on Medical Devices

Advanced Strategies and Tactics for Using the De Novo Pathway

How to Write Effective SOPs for Medical Devices

Advancing MRI Technology As We Know It Today

How to Make De Novo a Viable Option for your Medical Device

Understanding Post-market Surveillance under EU MDR: Being Proactive, not Reactive

How a Shift in Mindset Resulted in a Higher Quality IQ for this Industry Veteran

The 100th Episode: A Few of My Favorite Moments

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

Grasping the Impact of Artificial Intelligence and Machine Learning on Medical Devices

Why User Needs Matter & Their Benefits in Streamlining Device Design and Development

Greenlight Guru Launches New Podcast Series: MedTech True Quality Stories

Improving the Quality of Life in the Most Delicate Patient Group: Preterm Born Infants

How Sonavex Went from Concept to FDA Clearance in Just 3 Years

ISO 13485 Medical Device Quality System Standard and Other Regulatory Conundrums

Modernizing 510(k) Program through new FDA Safety and Performance Based Pathway

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

Why Document Control Matters To Medical Device Companies

Abbreviated 510(k): Substantial Equivalence Through Performance Criteria

The Greenlight Guru True Quality Roadshow: Atlanta Recap

Why Flexible Design Reviews Matter for Medical Device Product Development

Nonbinding Feedback is a New Guidance You Should Know About

Greenlight Guru Announces Digital Design Reviews for Medical Device Product Development Teams

UX for Medical Devices: Designing for the Evolving Environment of Technology, Safety, Regulation and Recalls

How and When to Consider Human Factors

How to Avoid Common Problems with your Design, Risk, and Validation Documentation

Quality, Fast, Cheap...Pick Two

Who Should Own Your QMS?

What to Expect During an FDA QSIT Inspection

Design Validation vs. Human Factors Validation

5 Most Common Problems with your CAPA Process

Medical Device Product Development Value Proposition

Prepping your QMS for EU MDR

Introducing The Greenlight Guru True Quality Roadshow 2019

When Design Input Requirements Go Wrong

Medical Device Change Management Best Practices [Free Webinar]

Best Practices for Effective Medical Device Design Reviews

Medical Device QMS Changes: How to Manage Changes Regarding EU MDR, IVDR & ISO 13485:2016

Quality Systems Management (QSM) vs. Quality Management System (QMS) - What's The Difference?

Proactive Quality Systems: FDA Is Prioritizing Them...And You Should Too

Aligning True Quality and Compliance with MDDAP

Why Contract Manufacturers Shouldn't Own Your Quality System

Explaining the Significance of Voluntary Consensus Standards

EU MDR: How do I interpret the new regulations and what do I need to do to be compliant?

FDA Case for Quality: 2018 Comprehensive Review

Medical Device Industry Predictions for 2019

Defining Your Medical Device Design Records

6 Predictions for the Medical Device Industry in 2019 (and how you can prepare)

ISO 13485 & MDSAP Deadlines are Fast Approaching (And You Need a Notified Body)

FDA Plans to Modernize 510(k) - Is the Sky Falling?

FDA Computer System & Software Validation - What You’ve Known For 20+ Years Is Changing

Understanding the Blurred Lines Between Consumer Tech and MedTech

3 Real World Document Management Horror Stories

Understanding The Differences Between Clearance vs Approval vs Granted

Looking to join a fun, fast growing SaaS company? Greenlight Guru is hiring (Again)!

Top 20 Medical Device Venture Capital Firms

Streamlining The Device Marketing Authorization Process

How to Create a Risk-based CAPA Process

The New Special 510(k)

FDA's Case for Quality Webinar Series

5 Myths Engineers Believe About Quality (and what is really true)

Greenlight Guru Announces New Integration with Jira Software

What's New With PMAs

The 510k and Substantial Equivalence: Why do so many get it wrong?

How To Drive Executive Engagement With Quality Systems (and actually get them excited about it)

How to Efficiently Raise Funds for Your Medical Device Company

5 QMS Elements that must Connect to your Design Control for an Effective, Audit Proof Process

Standards – Makes the Medical Device World go Around

Quality vs Compliance Metrics (and what's next for FDA's Case For Quality)

7 Habits of Highly Effective True Quality Medical Device Professionals

Regulatory Tips & Observations from a Former FDA Reviewer

FDA Aligning to ISO 13485:2016 (and Why It Matters)

Questions to Ask Before Hiring Your QA/RA Consultant

What it Means to be Focused on Quality vs. Compliance

How to Conquer Supplier Management for Medical Device Companies

What You Need to Know About The FDA CDRH Experiential Learning Program

What are the Regulatory Expectations for Software as a Medical Device (SaMD)?

Latest Updates on CDRH Standards Program & IEC 60601

The Importance of Good Document Management (And How To Do It)

Why the FDA Case for Quality Matters

15 Habits of Highly Effective Regulatory Professionals

Top 10 Most Significant Changes Introduced by the new EU MDR (And How to Avoid the Common Mistakes)

Greenlight Guru Announces Advanced Document Management

How to Embrace Risk for Safer Devices

Scaling Regulatory and Quality with Your Company

What you Need to Know about FDA's Progressive Programs

FDA Case for Quality Program: What, Why and How?

What Are the Regulatory Expectations for Software as a Medical Device (SaMD)?

AI Explainability: What That Means and Why it Matters in Healthcare

The Bleeding Edge: Lessons Learned for the Medical Device Industry

The Pre-Market Approval (PMA): Is it really as bad as so many think?

AI Explainability: What that Means and Why it Matters in the Medical Device Industry

Why Your Company Needs a QMS Software or eQMS

How Human Factors Impact Your Medical Device

How to Think About Quality and Regulatory as Your Company Scales

Challenging “Conventional Wisdom” in Medtech R and D

Quality VS Compliance Metrics & What's Next for FDA's Case for Quality Pilot

FDA's Case for Quality: Simplifying the Regulatory Activities

How to Design for Compliance with IEC 60601

FDA Proposes Allowing Medical Device Makers to Summarize Malfunctions: What does that Mean for You?

Understanding the Medical Device Single Audit Program (MDSAP) & How To Prepare for It [Free Webinar]

FDA’s Case for Quality: Voluntary Pilot Program Details and Status Update

Why There is a Need for Multi-Level Design Controls

How to Use the Abbreviated FDA 510(k) Pathway to Your Advantage

10 Things You Must Know About Updating Your Technical Files to Comply with EU MDR

FDA's Case for Quality: What, Why, and How? Changing the Regulatory Paradigm

What Medical Device Developers Should Know About Human Factors

How Priority Designs Used Greenlight Guru to Gain ISO 13485:2016 Certification

Creating an Effective Quality Culture that Benefits Your Patients

Debunking Premarket Approval (PMA) Myths (And Why the PMA Path May Not Be as Scary as You Think)

Sneak Peek Into the ISO 14971 Revision Process (From a Member of the Standard's Working Group, JWG1)

How to Implement (And Maintain) a Bulletproof Medical Device QMS

Tips, Tricks & Best Practices for Complying with ISO 13485:2016

Greenlight Guru Announces Multi-Level Design Control Software

Helping Prepare Biomedical Engineers Entering the Workforce

Competitive Regulatory Strategy vs. Regular Regulatory Strategy

A Timeline to Comply with ISO 13485:2016 (And What You Need to Be Doing Today)

How to Ensure Your Quality Management System is Effective and Benefits Patients

Timeline to ISO 13485:2016 (And Why You Need to Act Today)

7 Problems with a Paper-Based Design History File (And How to Avoid Them)

CAPA Process Mistakes You Want to Avoid

How to Prepare for a Successful Design Transfer [Free Webinar]

Understanding the New Requirements for QMS Software Validation in ISO 13485:2016

How to Determine the Operational Quality of a Quality System Using a Performance Assessment

Quality Management Audit or Assessment?

What Substantial Equivalence Means as It Applies to 510(k)'s & Why It's So Important

General Wellness Devices & Wearables: Regulatory Options You Need to Know

4 Tips for Handling Nonconformances

Regulatory Intelligence (Mis)Management in the Medical Device Industry

Understanding the Many Connotations of Risk in Medical Device Development [Free Webinar]

Ultimate List of Medical Device Incubators and Accelerators (50+)

How Software Can Be Leveraged to Streamline Device Development

Evaluating FDA’s “New” Proposed Fast-Track Alternative Approach to the 510(k) Pathway

5 Predictions for the Medical Device Industry in 2018 (And How You Can Prepare)

An Overview of What Medical Device Developers Need to Know About Human Factors

Demystifying the FDA's Human Factors Guidance

What You Need to Know About Medical Electrical Standards Updates

Challenges with Applying Risk Management Throughout the Manufacturing Process

13 Steps to Creating a Risk-Based CAPA Process

Common Mistakes That Can Tank Your FDA 510(k) Submission

What is Software as a Medical Device (SaMD)?

Understanding How to Use Real-World Evidence for Medical Device Regulatory Decisions

Here Are the 4 Types of FDA Inspections You Need to Understand

Greenlight Guru Extends Platform with New Product, Grow, to Streamline PostMarket Quality Processes

ISO 13485:2016 Transition Planning - Webinar

Medical Device Design Controls - Free Webinar Series

What You Need to Know About Life with FDA After Your Device Gains Clearance [Free Webinar]

How to Perform a Successful Internal Quality Audit [Free Webinar]

ISO 13485:2016 - Understanding the Changes

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

Lessons to Be Learned From Recent FDA Inspections

How MEDDEV 2.7.1 Rev 4 Affects Medical Device Manufacturers

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

Standard Conformity or Regulatory Compliance? Distinguishing the Two

What Does a Risk-Based QMS Mean?

What You Need to Know About the 510(k) Submission Process

Why You Need To Stop Treating Risk Management & Design Controls as Checkbox Activities

How Competitive Regulatory Strategy Differs from Regular Regulatory Strategy

The Do’s and Don’ts of an FDA Inspection

How to Translate Voice of Customer into User Needs

Comparing FDA Submission Types: 510(k) vs. De Novo vs. 513(g) vs. Pre-Submission

How to Retroactively Create Design Controls and DHF (Even Though You Should Never Let This Happen)

7 Common Mistakes That Can Delay Your FDA 510(k) Clearance

How Process Excellence Leads to Product Excellence

Debunking 8 Commonly Held CAPA Myths

How to Prepare Your Design History File (DHF) for an FDA Inspection

13 Common Pitfalls to Avoid During Medical Device Product Development

Design Validation vs. Clinical Evaluation: What’s the Difference?

5 Tips for Conducting Medical Device Management Reviews

Technical File vs. 510(k) vs. Design History File: What Medical Device Developers Should Know

How To Prepare for an FDA Inspection (Plus 5 Tips)

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

Understanding the Connection Between Complaints, CAPAs, and MDRs

When Design Inputs Go Wrong + Design Your Label Like You Design Your Device

EU MDR and IVDR Are Live – Here Are Some Important Items You Should Know!

Clinical Evaluation Reports — Things You Should Know About the MEDDEV 2.7/1 Revision 4

Better Root Cause Analysis for Safer, More Effective Medical Devices

The Intersection of Medical Device Usability and Risk Management

CAPA: When to Take Corrective Action or Preventive Action?

What is a “Quality Data Source” for your CAPA Process?

Tips for Conducting Better Root Cause Analysis for Medical Device Companies

This is a What … Unforeseen Pitfalls when Classifying a Medical Device

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

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

EN ISO 14971:2012 Risk Assessment Explained in 5 Minutes… Using the Grossest Example Ever?

Fundamentals of Supplier Management for Medical Device Companies

An Overview of What Device Makers Need to Know About CAPA

5 Tips for Medical Device Engineers on FDA Design Controls

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

How to Speed up your Product Development Process

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

4 Key Compliance Issues for Medical Device Companies

What is CAPA in the Medical Device Industry?

Key Challenges for Risk Management in Medical Device Development

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

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

5 Things the Medical Device Industry Should Expect in 2017 (And How You Can Prepare)

A Review of the Most Important Medical Device Industry Topics in 2016

5 Things the Medical Device Industry Should Expect in 2017 - Webinar

Using the Bucket Method for Medical Device Risk Management w/ Mike Drues

Effective Medical Device Product Development Project Management (And How To Avoid the Most Common Pitfalls) - Webinar

Tips for Success with IEC 60601 for Electrical Medical Devices

The Business Case for Integrated Design Controls

How a New Breed of Medical Device Companies Is Leveraging Technology to Get More Done with Less Resources

Medical Device Risk – ISO 14971 Gets It Right

Understanding the New FDA Guidance on Changes to 510(k)

An Introduction to FDA 21 CFR Part 11

What Devicemakers Need to Know about the FDA Pre-submission Process (Part Two)

Preparing for the Changes to the EU Medical Device and In-Virto Diagnostics Regulations

FDA 21 CFR Part 820 vs. ISO 13485:2016 vs. ISO 13485:2003

Tips for Avoiding Problems with the First-In-Human Study Process with Mike Drues

What's with the Rush to First-In-Human Studies?

Tips & Pointers for Effective Internal Quality Audits with Kyle Rose

How to Properly Use the FDA Pre-Submission Process and Why It's So Important with Mike Drues

Why Poor Design Controls Mean More Medical Device Complaints

Greenlight Guru Invited to Host Two Workshop Sessions at RAPS Convergence San Jose 2016

How To Avoid Being Part of the 69% of 510(k) Submissions That Get Rejected the First Time

Insider Tips and Best Practices Regarding the 510(k) Submission Process from a Former FDA Reviewer

Why Use ISO 14971 vs. FMEA (Template Included)

Insights Into the New FDA 3D Printing Guidance & How It Impacts Med Device New Product Development

Clinical Evaluation in the EU for Medical Devices: Understanding the Changes in MEDDEV 2.7.1 Rev 4 and Their Impact

What It Means to Join the Greenlight Guru Family

Recovery Force Accelerates Their Product Development Efforts Using Greenlight Guru [Case Study]

8 Reasons Why Your Design Controls And Risk Management Processes Fail

What Medtech Startups Should Know About Quality Systems To Not Go Overboard

Preparing Your Class II Device for the UDI Compliance Deadline with Gary Saner

FDA 510(k) Submission Tips, Tricks and Timelines from a Former FDA Reviewer [Free Webinar]

5 Medical Device Project Management Tips That Will Help You Complete Your Project On Time

7 Steps to Respond to FDA 483 Inspection Observations (Response Template Included)

Dirty Devices and Reprocessing: Are New Design Change Rules On the Horizon?

How to Prepare for the New EU Medical Device Regulations (MDR) [Free Webinar]

4 Medical Device Quality System Musts for Startups

4 Lessons I Learned Going Through an FDA / ISO Audit for the First Time as an Engineer

Tips to Help You Prepare for an FDA Inspection

How to Prepare for the New EU In Vitro Diagnostic Regulations (IVDR) [Free Webinar]

Top 9 Reasons Device Makers Received FDA Form 483 and Warning Letters in 2015

Understanding Risk in Medical Device New Product Development (NPD)

8 Steps You Should Be Taking to Implement an EU-MDR Compliance Program [Free Webinar]

How to Avoid Medical Device Product Development Wipeouts with Meghan Alonso

Is Your Company Disconnected from the Medical Device Regulations It Must Abide By?

15 Steps to Get Approval to IEC 60601-1 [Free Webinar]

Why the Conventional Wisdom Regarding ‘R’ and ‘D’ in Medtech Product Development Is Wrong

Acronyms You Need To Know When Evaluating Medical Device Software Solutions

Top 3 Document Management Tips for Medical Device Companies

How to Simplify Compliance to the new ISO 13485:2016 Quality Management Standard - Webinar

Medical Device Product Development Project Management Best Practices with Peter Sebelius

How To Navigate the Difficult Road of Medical Device Product Development While Avoiding the Common Pitfalls

4 Reasons Why Your Risk Management Approach is Wrong

Why Using the Proper Standards for Your Regulatory Submission is So Important with Leo Eisner

Best Document Management Practices for Medical Device Startups: Don’t Cheap Out

FDA 483 and Warning Letters: How to Avoid and Respond - Webinar

Risk Management for Medical Devices - Webinar

An Insider’s Look at the Changes Coming in ISO 13485:2016 with Mark Swanson

The Greenlight Guru Advantage - More Than QMS Software [Customer Video Testimonial]

Why Medical Device Startups Need to Implement a ‘Right-Sized’ QMS with David Amor

Why Getting FDA 510(k) Clearance Alone is Not Enough (And 6 Things You Can Do About It)

Why Design Inputs Are So Important to the Success or Failure of Your Project with Matt Romey

LITG Case Study: Easily Documenting Design Controls to Accelerate Product Development

Sandstone Diagnostics Case Study: Moving from a Paper-based QMS to Greenlight Guru

5 Reasons Why You Need To Implement a QMS or Bust

How To Identify, Quantify & Manage Enterprise Risks for Medical Device Companies with Mike Cremeans

How To Avoid Major Common Mistakes During the 510(k) Process with Michael Drues

Tips, Tricks and Pointers for MedTech Startup Entrepreneurs With Mitch Levinson

Greenlight Guru Wins 2015 Indiana Innovation Award

The Many Connotations Of Risk In Medtech Development — And The Consequences Of Getting Them Wrong

Sara Naab On Going From Idea to Funding to One of the Bay Area's Most Innovative Life Sciences Co's

Does Your Medical Device Startup Suffer from CEO Disconnect Syndrome?

Risk Management from a Regulatory & Product Development Point of View

How To Flush $400,000 Down the Drain Fighting the FDA

How to Improve Your Medical Device Design Reviews Bonus Episode

Design Reviews – Are More or Less Better?

A Brief Introduction to Medical Device Risk Management (Plus 5 Tips)

How To Improve Your Medical Device Design Reviews

How To Avoid a Medtech Documents & Records Scavenger Hunt

Join Us in Memphis for #ZeroToGreenlight - Why Worrying About FDA Regulations Matters

Should design controls have prevented the recent reprocessing tragedy: Do we need new regulation?

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

Best Practices for Implementing Design Controls for the Medical Device Industry

2 Things You Need To Do ASAP When Starting A Medical Device Project

How To Reduce & Prevent Medical Device Complaints

Changing Medical Device Design Control

You do know Design Controls are required for medical devices, right?

An FDA Inspection Will Happen

Design Controls are the #1 Most Cited Issue with FDA

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CHECKLIST/TEMPLATE

17 resources bundled into 1 free download for product developers to accelerate bringing a device to market.

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Product Development

Explore valuable insights and best practices in product development for medical devices.

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eBook

Complete Guide to Bringing a Medical Device to Market

eBook

The Ultimate Guide To Design Controls For Medical Device Companies

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eBook

Learn what is expected from regulators & how to leverage risk as a tool with this comprehensive guide.

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Risk Management

Explore valuable insights and best practices in risk management for medical devices.

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eBook

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

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ISO 14971:2019 Gap Analysis Tool

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CHECKLIST/TEMPLATE

This content bundle is packed with resources tailored specifically to help medical device companies run efficient clinical investigations while ...

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Clinical Data Collection & Management

Explore valuable insights and best practices in clinical data collection and management for medical devices.

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eBook

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

eBook

Ultimate Guide to Clinical Data Management in MedTech

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eBook

A guide to breaking down the different options your medical device company has for a QMS solution and help you make an informed decision that’s ...

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Quality Management

Explore valuable insights and best practices in quality management for medical devices.

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eBook

ISO 13485 for Medical Devices QMS - The Ultimate Guide

eBook

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

Webinars

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Upcoming

September 12, 2024

Preparing a Successful FDA Medical Device Submission

Join us for an exclusive webinar led by a former FDA reviewer where you'll gain insider knowledge and practical strategies to ensure your product submission stands out for all the right reasons. Whether you're a seasoned MedTech professional or new to the go-to-market process, you'll learn actionable insights that will help you avoid costly delays and position your device for a successful review and approval.

On Demand

August 20, 2024

Maximizing Value from Design Controls: Strategies for Medical Device Companies

Join us for a deep dive into design controls with actionable tips and advanced strategies. Discover proven best practices by stage, practical applications, and the financial and safety impacts of noncompliance.

August 20, 2024

Integrating Clinical Strategy and Project Management for Cost-Effective Clinical Investigations

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August 13, 2024

EU MDR Hot Takes: Evolution or Overreach?

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Post-market Surveillance

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Understanding Post-market Surveillance under EU MDR: Being Proactive, not Reactive

During this free 60 minute webinar hosted by Carolyn Guthrie, Director of QA/RA at Kapstone Medical, you will learn why it is important that PMS is not a one-size fits all approach, with considerations for risk of device, lifetime of device, time of the market, and more.

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Ultimate Guide to Postmarket Surveillance of Medical Devices

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Selecting the Ideal PMCF Activity

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

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Audits & Inspections

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FDA QSIT: Preparing Your Medical Device Company for an Inspection

If you prepare well in advance of an inspection, not only can you reduce these fears, but you can find that your company can actually reap many benefits.

13 Tips For Audit Etiquette Every Medical Device Company Should Know

Learn proven and effective tips and pointers for preparing for an audit and ensuring it runs smoothly from a certified Lead Auditor for ISO 13485.

The Ultimate Internal Audit Checklist Every Medical Device Company Needs

The ultimate internal audit checklist you can begin using today to ensure every system, process, & operation associated with your device is performing at its best.

The Definitive Guide to Responding to FDA 483 Observations and Warning Letters

A detailed guide regarding exactly how to respond to FDA 483 observations and warning letters.

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Global Medical Device Podcast

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Determining User Needs for Your Medical Device

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Understanding the ROI of an eQMS

In this episode we explore the return on investment of a purpose-built electronic Quality Management System ...

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Regulatory Strategy and the Advantage of Diversity in MedTech

This episode covers crucial topics such as biases in medical device testing, evolving FDA approaches, and the ...

Most Recent Resources

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Who Owns the Design Controls Process?

This episode covers the importance of ownership in design and development documentation, the complexities of design controls, and practical insights on how to ensure compliance and streamline product development.

Preparing a Successful FDA Medical Device Submission

Checklist/Template

Complaint Log + Form Template Bundle

Greenlight Guru Clinical & BSI Life Sciences: Live Demo Integration

Maximizing Value from Design Controls: Strategies for Medical Device Companies

EU MDR Hot Takes: Evolution or Overreach?

Integrating Clinical Strategy and Project Management for Cost-Effective Clinical ...

Focus on the Work That Matters Most.

See how Greenlight Guru’s MedTech Suite can help you eliminate the repetitive, low-value tasks of your day-to-day with a personalized demo.

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