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

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

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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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Webinars

Free training webinars to help medical device professionals keep up with best practices.

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Webinar

Predetermined Change Control Plans (PCCP): Approving medical device changes before you make them!
Webinar

How much clinical data do you actually need: Have we overestimated the EU requirements?
Webinar

The Importance of Integrating Regulatory Early into Product Development
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Integrating Risk Management & CAPA: How to Supercharge Your Medical Device Quality
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Clinical Submission Do's & Don’ts: Tips from a Former Notified Body Expert
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How to Best Prepare for FDA QMSR
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Preparing a Successful FDA Medical Device Submission
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Greenlight Guru Clinical & BSI Life Sciences: Live Demo Integration
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Maximizing Value from Design Controls: Strategies for Medical Device Companies
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Integrating Clinical Strategy and Project Management for Cost-Effective Clinical Investigations
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EU MDR Hot Takes: Evolution or Overreach?
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Live with FDA: Accelerating a Quality Culture at Your Medical Device Company
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Global UDI Updates: Navigating EUDAMED Changes & Health Authority Trends
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From LDTs to IVDs: Navigating the New Regulatory Landscape
Webinar

Strategies for Navigating the EU MDR Extension Deadlines
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Enhancing Clinical Data Collection with Greenlight Guru Clinical's Add-ons
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Decoding 'Sufficient Clinical Evidence' under EU MDR for Medical Devices
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Enhancing Post-Market Activities with Greenlight Guru’s Quality Event Workflows
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IEC 62366-1 Essentials: Elevating User Safety in Medical Devices
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Revolutionizing Medical Device Trials with Risk-Based Monitoring
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Mastering Document and Change Management with Greenlight Guru Quality
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Designing Effective PMCF Surveys in Greenlight Guru Clinical
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Conducting Effective FDA Pre-Sub Meetings: Best Practices to Avoid Timely & Costly Mistakes
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Live Q&A with FDA: Cybersecurity Premarket Guidance
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Key Expectations for ISO 14971 Compliance with Implementation of QMSR
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QMSR Final Rule: Meeting FDA’s New Requirements
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Insights from TÜV SÜD and Greenlight Guru on the Requirements of PMCF under the MDR 2017/745
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Leveraging Automated Training with Greenlight Guru Quality
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eSTAR 5.0: Are You Ready?
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Significant Risk vs. Nonsignificant Risk Devices: What’s the Difference & Why Does It Matter?
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Integrating Risk Management Throughout the Entire Device Lifecycle with Greenlight Guru Quality
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Streamline Your Clinical Data Management with Greenlight Guru Clinical's Reporting Module
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Key Elements to Outsourcing Clinical Activities in 2024
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UDI Product Data and EUDAMED, Get Onboard!
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Achieving Real-Time Audit Readiness Using Greenlight Guru Quality
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Integrating eCRF and ePRO in One Single Platform
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Demystifying FDA’s Pre-Market Final Guidance
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Maximizing Clinician Participation in Post-Market Operations
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Streamlining Your Medical Device Development with Greenlight Guru QMS: Live Demo
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Mastering Medical Device Audits: A Proven Formula
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Best Practices for Patient Recruitment in MedTech Clinical Studies
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How Quality & Regulatory Compliance Drive Financial Performance in MedTech
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Upgrading Your QMS Solution: Practical Tips & Tricks for a Seamless Transition
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Demonstrating Conformity to General Safety and Performance Requirements (GSPR) under MDR
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How to Boost Patient Recruitment in Greenlight Guru Clinical
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Align Your Clinical Claims with the Clinical Investigation Performance and Safety Endpoints
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Live eCRF Setup and Forms Building in Greenlight Guru Clinical
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Data Management and Monitoring in MedTech Clinical Studies
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QSR to QMSR: The Rewrite of 21 CFR Part 820 & Key Considerations for FDA Compliance
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Busting Mythconceptions about FDA’s Refuse-to-Accept Policy for Cybersecurity
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How to Validate an Electronic Data Capture Setup for a Medical Device Clinical Investigation
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Preparing Your Technical Documentation under MDR: Proven Tips & Techniques
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Developing IEC 62304 Compliant Software: Proven Tips & Best Practices
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Global UDI Update: Including FDA “Devices Not in GUDID” Letters and EU Legacy Device Extension
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How to Design the Optimal eCRF for Clinical Investigations
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Showing Substantial Equivalence in All Types of 510(k)s: Minimizing Time & Cost to Market
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Understanding the ROI of an eQMS Solution
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Pre-Market Medical Device Studies and GCP - Strategies for Success
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Implementing Risk Throughout the Entire Product Lifecycle
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The Ugly Truth About Paper-Based QMS - Making the Switch to eQMS
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How To Gain Better Access to Healthcare Decision Makers
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How to Show ROI on Your Clinical Evidence
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Modernizing Your QMS to Reduce Risk, Improve Quality & Drive Innovation
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How to Create Your DHF/TF & RMF for a Hardware or Software Medical Device
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MDR by the Numbers: Leveraging New Data for Implementation Planning
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Refuse to Accept (RTA) & Additional Information Requests (AIR): How to Avoid Problems with Your Medical Device Submission
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5 Tips for Designing a Medical Device Study under US FDA Requirements
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How to Use Clinical Data for Medical Device Submissions in both EU & US
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Mastering the Design Transfer Process
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Best Practices for Structuring Clinical Data in Medical Device Studies
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FDA Digital Health Updates: What changed in 2022 and what should you expect in 2023?
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Regulatory Due Diligence: Why Pay for Information You Can Get for Free?
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Monetizing Software: The Challenges of Commercialization & How to Overcome Them
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How to Prepare for IVDR
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Extending IEC 62304’s Software Lifecycle Principles to Electrical and Mechanical in Medical Device Design
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Usability Testing: Why can’t we get it right?
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Connecting Computer System Validation to Daily Operations
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How to Ensure Your State of Affairs for EU MDR is State of the Art
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MDR Transition and Tech File Changes: What Medical Device Companies Need to Know
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Integrating Cloud & Modern Computing Technologies into the Operation of Your Medical Device
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How to Prepare for the FDA Pre-Submission Process - Free Webinar
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Bridging the Gap Between Development and Regulatory Teams
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How to Survive an FDA Inspection
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Special Controls: What Are They & How Can We Use Them To Our Advantage?
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Bridging User Needs & Design Requirements
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How to Integrate Risk Management throughout the Product Lifecycle in the Coming Decade
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How to Proactively Predict & Mitigate Risk throughout the Supply Chain
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Letter-to-File 101: Are You Sure You're Preparing Yours Correctly?
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Is Regulation Necessary for Quality? How to Improve Your Product & Bottom Line with Compliance & a QMS
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Strategies for Ensuring a Medical Device released under EUA will stay on the market after EUA expires
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How to use eConsent Efficiently in Medical Device Studies
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Building Your BOM: 3 Ways To Manage Your Product Information With Full Traceability
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How to Ace Your Internal Audits in 2022
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How to Effectively Implement the New ISO 14971:2019 & Maintain Your Current Risk File
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Breakthrough Device Designation & Its Impact on Reimbursement
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Notified Body + Manufacturer Face-off: Inside Scoop from Both Sides on How to Address MDR Misalignment
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The “New” 510k: How Do You Show Substantial Equivalence Without Using A Predicate?
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The Power of 3D-Printed Medical Devices: Proven Regulatory Strategies & Quality Recommendations to Use for Additive Manufacturing
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Tips & Tricks for Customizing a Clinical Trials Program for your Medical Device, IVD, or Digital Therapeutic that Satisfies Regulators, Investors & Patients
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Human Factors Engineering: The Worldwide Guide for Medical Device Manufacturers
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Demystifying the Breakthrough Device Designation (BDD) & Safer Technologies (STeP) Processes
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5 Key Points to Consider in Design Transfer of Medtech
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FDA vs. EU Regulatory Pathways: Factors Every Startup Must Consider with Go-to-Market Strategy
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Attention ⚠️ ISO 15223-1 4th Edition is Almost Here: How to Update your Medical Device Labeling to Comply with the New Requirements
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Combination Products: What Are They, Why Are They Important & Why Should Medical Device Professionals Care?
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How to Prepare for and Manage Audits/Inspections across Global Markets
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Evaluating need for Biocompatibility Testing & Mitigating Risks when Changing your Medical Device
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How to Integrate Cybersecurity into Your Existing Medical Device Development Lifecycle
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Change Management and Risk Management: How do we connect the dots and what happens if we don’t?
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3 Powerful Ways to Revolutionize your Approach to Closed-Loop Quality System Traceability
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When Do We Need FDA’s Permission to Market Our Device and When Do We Not?
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Best Tools & Tricks for Meeting IVDR Requirements to Obtain CE Marking
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How to Implement and Maintain a Modern CAPA System while Avoiding Common Pitfalls
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Insider’s Look at the IEC 60601 Amendments: Detailed Guidance from Committee Member Responsible for Changes
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Verification & Testing Strategies for Compliance with ISO 13485:2016, IEC 62304 / 60601-1 / 82304-1
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Understanding the Medical Device Classification System: From Basics to Beyond – Using Classification to your Competitive Advantage
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How can Medical Device Companies use the Emergency Use Authorization (EUA) to Address the COVID-19 Pandemic?
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3 Ways Medical Device Companies Working Remote are Leveraging QMS Software to Foster Innovation and Collaboration
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How to Estimate Sample Size for Medical Device Clinical Studies
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How to Use UX to Streamline Medical Device Product Cycles
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Are You Sure You Know the Best Regulatory Pathway for Your New Medical Device?
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Beyond Design Controls 101: Following the Regulation vs. Understanding Its Intent
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Implementing Best Practice Medical Device Change Control Processes (While Avoiding Common Pitfalls)
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An Exclusive Look at the New Changes to ISO 14971:2019 & TR 24971:2019
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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?
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How and When to Start Documenting Your Design Controls with DHF Ready Ideation
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How and When to Register EU Medical Devices and Report UDI Information to EUDAMED
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How to Apply Risk Management Throughout the Product Lifecycle of your Medical Device
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10 Steps to Preparing Your 510(k) Submission (And How to Avoid the Common Pitfalls)
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Breakthrough Designation Program: Is this an option for my medical device?
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Why Design Validation is More Than Testing: How do we validate our validation?
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Advanced Strategies and Tactics for Using the De Novo Pathway
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Understanding Post-market Surveillance under EU MDR: Being Proactive, not Reactive
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Why User Needs Matter & Their Benefits in Streamlining Device Design and Development
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UX for Medical Devices: Designing for the Evolving Environment of Technology, Safety, Regulation and Recalls
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How to Avoid Common Problems with your Design, Risk, and Validation Documentation
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Prepping your QMS for EU MDR
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When Design Input Requirements Go Wrong
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Medical Device Change Management Best Practices [Free Webinar]
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EU MDR: How do I interpret the new regulations and what do I need to do to be compliant?
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How to Create a Risk-based CAPA Process
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FDA's Case for Quality Webinar Series
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The 510k and Substantial Equivalence: Why do so many get it wrong?
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5 QMS Elements that must Connect to your Design Control for an Effective, Audit Proof Process
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Standards – Makes the Medical Device World go Around
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How to Conquer Supplier Management for Medical Device Companies
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Top 10 Most Significant Changes Introduced by the new EU MDR (And How to Avoid the Common Mistakes)
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The Pre-Market Approval (PMA): Is it really as bad as so many think?
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FDA's Case for Quality: Simplifying the Regulatory Activities
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Understanding the Medical Device Single Audit Program (MDSAP) & How To Prepare for It [Free Webinar]
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FDA’s Case for Quality: Voluntary Pilot Program Details and Status Update
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10 Things You Must Know About Updating Your Technical Files to Comply with EU MDR
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FDA's Case for Quality: What, Why, and How? Changing the Regulatory Paradigm
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How to Implement (And Maintain) a Bulletproof Medical Device QMS
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A Timeline to Comply with ISO 13485:2016 (And What You Need to Be Doing Today)
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How to Prepare for a Successful Design Transfer [Free Webinar]
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General Wellness Devices & Wearables: Regulatory Options You Need to Know
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Regulatory Intelligence (Mis)Management in the Medical Device Industry
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Understanding the Many Connotations of Risk in Medical Device Development [Free Webinar]
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How Software Can Be Leveraged to Streamline Device Development
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Demystifying the FDA's Human Factors Guidance
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What You Need to Know About Medical Electrical Standards Updates
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ISO 13485:2016 Transition Planning - Webinar
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Medical Device Design Controls - Free Webinar Series
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What You Need to Know About Life with FDA After Your Device Gains Clearance [Free Webinar]
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How to Perform a Successful Internal Quality Audit [Free Webinar]
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ISO 13485:2016 - Understanding the Changes
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5 Things the Medical Device Industry Should Expect in 2017 - Webinar
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Effective Medical Device Product Development Project Management (And How To Avoid the Most Common Pitfalls) - Webinar
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Clinical Evaluation in the EU for Medical Devices: Understanding the Changes in MEDDEV 2.7.1 Rev 4 and Their Impact
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FDA 510(k) Submission Tips, Tricks and Timelines from a Former FDA Reviewer [Free Webinar]
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How to Prepare for the New EU Medical Device Regulations (MDR) [Free Webinar]
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How to Prepare for the New EU In Vitro Diagnostic Regulations (IVDR) [Free Webinar]
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8 Steps You Should Be Taking to Implement an EU-MDR Compliance Program [Free Webinar]
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15 Steps to Get Approval to IEC 60601-1 [Free Webinar]
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How to Simplify Compliance to the new ISO 13485:2016 Quality Management Standard - Webinar
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FDA 483 and Warning Letters: How to Avoid and Respond - Webinar
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Risk Management for Medical Devices - Webinar

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