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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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Blog

Creative Clinical Recruitment: 4 Steps to Overcome Barriers to Participation
Blog

Medical Device Compliance: Regulations, Standards, and Solutions
Blog

Enhanced Consenting Options for Clinical Studies
Blog

The FDA Medical Device Approval Process: Pathways, Timelines, and Tips
Blog

FDA's Predetermined Change Control Plan: What's in the New Draft Guidance
Blog

Quality Management Consulting: How and When to Seek Help
Blog

Building an Effective CAPA Program: Key Steps and Common Challenges
Blog

Why Your Company Needs a QMS Software or eQMS
Blog

Market Access vs Adoption: Why Your Class II Device Needs Clinical Evidence
Podcast

The Danger of In-Home Use Medical Devices, Pt. 2
Podcast

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

The Trouble with Home-Use Devices, Pt. 1
Podcast

Insights from an Ex-FDA Investigator: Compliance, Quality Systems, and MedTech Trends
Blog

Real-World Data and Real-World Evidence: When and How to Use Them
Podcast

What Standards Apply to My Device?
Blog

Ultimate Guide to In Vitro Diagnostic (IVD) Devices
Blog

A Free CAPA Template for the Medical Device Industry
Podcast

Design of Experiments - How and When to Use DOE
Blog

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

Cybersecurity for Medical Devices: Best Practices from Regulatory Standards
Podcast

MedTech Advice from an Accidental Entrepreneur
Blog

Strategies for Successful PMA Submissions: A Guide for Clinical Teams
Podcast

Navigating the Complex World of Combination Products
Blog

Top 100 Medical Device Acronyms & Terminology You Need to Know
Blog

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

Meet the Guru: Building Quality Management in Early-Stage Medical Device Companies
Podcast

Who Owns the Design Controls Process?
Blog

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

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

Designing a Medical Device for a Global User
Podcast

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

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

Data Management and Reporting in FDA-Regulated Clinical Trials
Blog

Biocompatibility Testing for Medical Devices 101
Blog

Direct to Consumer - The Future of Healthcare
Blog

How 4 Pre-Market MedTech Companies are Leveraging Greenlight Guru Quality
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Quality Management Audit or Assessment? The Differences Explained
Blog

A Guide to Bridging User Needs Into Design Requirements
Blog

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

MDR and IVDR: Challenges and Opportunities of the New Regulations
Podcast

Clinical Evidence: The Key to Market Adoption
Blog

Paper Systems Are the Riskiest Way to Manage Medical Device Projects
Blog

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

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

2024 Greenlight Guru True Quality Roadshow: Copenhagen Recap
Podcast

Creative Clinical Recruitment
Blog

Why FMEA is Not ISO 14971 Risk Management
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How to Define Your Design Inputs and Design Outputs
Blog

How to Carry Out PMCF Activities According to EU MDR
Podcast

Getting Hired In MedTech
Blog

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

Achieving ISO 13485 Certification
Blog

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

Meet a Guru: Jamie Bihary
Blog

3 Types of QMS Audits (Plus 3 Tips to Prepare for Them)
Podcast

Advice to Medical Device Inventors
Blog

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

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

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

Obtaining Institutional Review Board (IRB) Approval
Blog

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

Interviewing the Interviewer
Blog

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

Ultimate Guide to Device Class Requirements under EU MDR
Podcast

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

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

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

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

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

ISO 14971 Risk Management for Medical Devices: The Definitive Guide
Blog

How are Medical Devices Classified under EU MDR?
Blog

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

Building a Partnership with your Regulatory Consultant
Podcast

Bringing a Self-Funded Medical Device to Market
Blog

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

Managing Risk in Clinical Investigations
Blog

Definitive Guide to Change Management for Medical Devices
Podcast

Speaking the Language of IVD
Blog

Top 50 Medical Device Product Design and Development Companies
Podcast

Is It Possible to "Buy" a QMS?
Blog

Ultimate Guide to Clinical Data Management in MedTech
Blog

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

What is a Class III Medical Device in the US?
Blog

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

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

Project Management in MedTech
Blog

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

Medical Device Classifications - How To Determine Your Device Class
Blog

ISO 13485: Ultimate Guide to Medical Devices QMS
Blog

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

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

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

FDA's Voluntary Improvement Program
Blog

The Ultimate Guide To Design Controls For Medical Device Companies
Blog

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

The State of UDI Across the World
Blog

How to Structure your Medical Device Technical File
Blog

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

Outsourcing Clinical Activities in 2024: Choosing A CRO
Blog

Quality Assurance vs. Quality Control in the Medical Device Industry
Blog

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

How MHRA is Regulating Medical Devices in the UK after Brexit
Blog

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

Quality Myths & Lessons Learned Part II
Blog

5 Habits of Highly Effective MedTech Companies
Podcast

Mastering the Pitch: MedTech Innovations from Concept to Market
Blog

How to Use the Turtle Diagram for Better Internal Audits
Blog

Greenlight Guru Announces the 2024 True Quality Roadshow
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Clinical Data Collection - 7 Key Pitfalls To Avoid In MedTech
Podcast

Becoming a MedTech Regulatory Affairs Professional
Blog

Top Medical Device Conferences To Attend in 2024
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FDA Publishes Final Rule on QMSR
Blog

Introducing Risk Reviews for Efficient, Compliant Risk Management
Blog

Calculating Nonconformance Costs in the MedTech Industry
Blog

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

How Artificial Intelligence is Impacting the MedTech Industry
Blog

Greenlight Guru Finishes 2023 with Strong Momentum in Q4
Podcast

Fundamentals of Quality & Regulatory
Blog

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

Navigating Clinical Evaluations and Investigations in MedTech
Podcast

The State of AI & Clinical Investigations
Blog

How PLM and QMS Solutions Work Together in MedTech
Podcast

The Evolving Landscape of AI in MedTech
Blog

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

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

Greenlight Guru’s MedTech Suite Named a Leader in G2 Winter 2024 Grid Report
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Customers Rank Greenlight Guru Quality as Medical QMS Leader in G2 Winter 2024 Report
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Greenlight Guru Clinical: Leader in the EDC Category in G2 Winter 2024 Grid Report
Blog

Most Popular Medical Device Content in 2023
Podcast

Considerations for IVD
Blog

Moving MedTech Forward: Greenlight Guru’s 2023 in Review
Blog

Top 40+ Medical Device Contract Research Organizations (CROs)
Podcast

Human-Centered Design in Medical Devices
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Electronic Data Capture (EDC) Buyer’s Guide: Making the Business Case for a New EDC System
Podcast

FDA's eSTAR Program
Blog

AI, Automation, and Risk in MedTech
Blog

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

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

Using AI in MedTech
Blog

The Ugly Truth About Managing Design Controls on Spreadsheets
Podcast

Becoming an Advisor to a Medical Device Company
Blog

Enterprise Quality Management Software: What You Need To Know
Podcast

Recent FDA Draft Guidances
Blog

Ultimate Guide to Supplier Management for Medical Device Companies
Blog

Greenlight Guru Releases The AI in MedTech Trend Report 2023
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The AI in MedTech Trend Report 2023 Is Here
Blog

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

Planning an FDA Submission
Blog

Benefits of Switching from MasterControl to Greenlight Guru
Blog

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

Ultimate Guide to Software as a Medical Device (SaMD)
Blog

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

What NOT to say to FDA
Blog

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

Greenlight Guru Expands Market Leadership with Strong Momentum in Q3 2023
Blog

IVDR for In Vitro Diagnostic Medical Device Companies - Ultimate Guide
Blog

5 Foundational Steps of a CAPA Quality Process
Podcast

Understanding LDTs & the FDA Proposed Ruling
Blog

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

EU MDR - 9 Top Questions Answered (European MDR)
Blog

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

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

UDI and EUDAMED: Past, Present and Future State
Blog

MHRA Guidance Document on Clinical Investigations in UK
Blog

Guide to Understanding AI Applications that Drive Business Value in MedTech
Podcast

Selecting a Site for Your Clinical Trial
Podcast

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

Greenlight Guru Celebrates 10 Years by Introducing its Multi-Product MedTech Suite
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Introducing The Greenlight Guru MedTech Suite: A Comprehensive Set Of Industry-Specific Solutions
Blog

Ultimate Guide to ISO 14155:2020 for Medical Devices
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How To Approach Supplier Corrective Action Requests (SCAR)
Blog

5 Tips for Medical Device Registration across Global Markets
Blog

Engineering Change Order: Its Role in the Change Management Process
Podcast

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

Greenlight Guru Yet Again Ranked as a Leader in QMS and Medical QMS Categories in G2 Fall 2023 Grid Reports
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How to Structure a Clinical Investigation Report (CIR) Summary
Podcast

Accelerating SaMD Development in a Compliant Agile Way
Blog

Creating a Supplier Scorecard for Medical Device Supplier Management
Blog

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

MedTech Funding and Preparing for Due Diligence
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3 Tips for Adding Flexibility to Your MedTech Manufacturing Supply Chain
Podcast

Exploring Breakthrough Device Designation
Blog

What is the FDA Medical Device Registration Process?
Blog

Machine Learning, AI and Risk Management: TIR34971 Explained
Podcast

Regulatory Strategy and the Advantage of Diversity in MedTech
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How to Comply with HIPAA and EU GDPR in Medical Device Studies
Blog

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

Conducting Quality Investigations in Medical Device Manufacturing
Podcast

28 Days To Save The World - True Quality Roadshow
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Omnibus Act Impact on Medical Device Cybersecurity
Blog

Boost Efficiency and Decision-Making with Enhanced Clinical Data Reporting
Podcast

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

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

FDA Guidance on Artificial Intelligence (AI) in Medical Devices
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Greenlight Guru Continues Strong Growth in Q2 2023 Powered by Product Innovation
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How to Improve Detecting, Correcting, and Preventing Nonconformances
Blog

Ultimate List of ISO Standards for Medical Devices
Podcast

The Role of dFMEA in Risk Management for Medical Devices
Podcast

Understanding the ROI of an eQMS
Podcast

CSA vs. CSV: Modern Validation for Modern MedTech
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eQMS Buyer’s Guide: Making the Business Case for a New QMS Solution
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Identifying and Evaluating Medical Device Importers
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Writing a Clinical Investigation Plan (CIP): The Essential Guide
Podcast

Management Responsibility: The most important part of a QMS
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15 Questions to Ask QMS Software Vendors in the Medical Device Industry
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How to Develop a Risk-Based Approach to Supplier Management
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Customers Rank Greenlight Guru Leader in QMS and Medical QMS Software in G2 Grid Reports for Summer 2023
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Alternatives to PMCF Clinical Investigations
Podcast

The Combination Products Handbook
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15 Reasons Why Medical Device Companies Choose Greenlight Guru
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How to Manage Complex Downstream Design Changes to Your Medical Device
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Purpose-Built QMS vs General-Purpose QMS: What You Can Expect From Each
Podcast

Leaning into Lean Documentation
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Greenlight Guru Publishes Independent Study Showing the ROI of eQMS Solutions on MedTech Companies
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How to Plan and Budget for MedTech Clinical Activities
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CSV vs. CSA: Exploring FDA’s New Software Validation Approach
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Making the Business Case for an eQMS Solution for Your Company
Podcast

Cybersecurity and the Future of MedTech
Blog

Greenlight Guru Modernizes Validation Approach to Streamline Software Implementation and Adoption for Medical Device Companies
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Managing Major Changes to Medical Device Packaging
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5 Tips for Designing a Medical Device Study Under FDA Requirements
Blog

What is a Modern QMS?
Blog

4 Tips for Managing Your MedTech Portfolio
Podcast

Ad Promo and The Difference in Regulatory & Legal
Blog

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

2023 Greenlight Guru True Quality Roadshow: San Jose Recap
Podcast

How AI Can Help You Manage Risk
Blog

How To Vet Medical Device Distributors in Multiple Markets
Blog

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

7 Tips for FDA 21 CFR Part 11 Compliance
Podcast

The Tools that Make Clinical Investigations
Blog

Understanding ISO 14971 Medical Device Risk Management
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eIFU Requirements: Everything You Need to Know About Electronic Instructions for Use
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5 Dos and Don'ts when Choosing a QMS Solution for Your Medical Device Company
Blog

Introducing Risk Solutions: A New Era in Risk Management for MedTech
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Greenlight Guru Launches AI-Powered Solutions to Enable Better Risk Management for the MedTech Industry
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How to use the Greenlight Guru Clinical AE/SAE reporting module
Blog

Planning Your Medical Device Global Market Regulatory Strategy
Podcast

Complaint Handling with Medical Device Guru, Brittney McIver
Blog

Why Clinical Data Is Essential to Value-Based Healthcare
Blog

3 Things to Love about Internal Audits
Blog

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

Avoiding Potential Issues with your 510(k) Submission
Blog

4 Advantages of an eQMS Over a Paper-Based QMS
Podcast

Meet a Guru: Brittani Smith
Blog

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

Greenlight Guru Builds Strong Momentum in Q1 2023 as Medical Device Companies Move to Modern Digital Solutions
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4 Reasons to Stop Mixing Your Clinical Data Collection Methods
Blog

How To Avoid a Failed QMS Implementation
Blog

5 Steps for Getting your CE Marking with EU MDR Requirements
Blog

2023 Greenlight Guru True Quality Roadshow: Houston Recap
Podcast

Why Building Supplier Relationships Is So Important
Blog

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

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

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

Systematic Literature Review for EU MDR
Blog

Greenlight Guru Introduces Export API for a Connected Quality Management System
Blog

5 Tips for Running Effective Internal Quality Audits
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eBOM vs mBOM: What’s the Difference?
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Medical Device Adverse Event Reporting Regulations: EU vs. US
Podcast

Building Your Design Controls (and Pitfalls to Avoid)
Blog

Electronic Data Capture Systems vs. Paper-based Data Collection
Blog

How to Handle Medical Device Adverse Events
Blog

Explaining IVDR Classification for In Vitro Medical Devices
Podcast

Most Common Problems Found During FDA Inspections in 2022
Blog

Complete Guide to Bringing a Medical Device to Market
Blog

Making the BOM & Design Controls Connection
Blog

Best QMS Software: Ultimate Guide to Comparing Quality Management System Solutions
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Clinical Data Management System (CDMS) for Medical Device Clinical Trials
Blog

Everything You Need to Know About Electronic Data Capture (EDC) for Clinical Trials
Podcast

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

Top 30 MDCG Guidance Documents for Medical Device Companies
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Top 40 IMDRF Technical Documents for Medical Devices
Blog

Good Clinical Practice (GCP) Compliance in Clinical Data Collection
Podcast

Understanding the 'Compliance Manager' Role
Blog

21 CFR Part 11: A Complete Guide
Blog

Research shows eCRFs faster, more reliable than paper CRFs
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How to Define User Needs During Design Controls
Blog

Greenlight Guru Introduces Newly Expanded Global Partner Program
Podcast

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

Does My Device Labeling Comply with 21 CFR 801?
Blog

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

Ultimate Guide to Postmarket Surveillance of Medical Devices
Blog

7 Essential Steps of a Nonconformance Report
Blog

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

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

What is a Class 1 Medical Device?
Podcast

How Communication Affects the Outcomes of Quality Activities
Blog

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

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

Top 100 Medical Device Companies (Free Chart Included)
Podcast

Part 2: The Theranos Loophole & Lab Developed Tests
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How Electronic Data Capture is Transforming the MedTech Industry
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5 Processes You Need to Invest In to Bring a Device to Market
Blog

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

What is a Document Control System?
Podcast

Part 1: The Theranos Loophole & Lab Developed Tests
Blog

The Pitfalls of Using Paper and Excel for Clinical Data
Blog

How to use eConsent Efficiently in Medical Device Studies
Blog

Tips for Ensuring Your Clinical Data Complies with FDA's 21 CFR Part 11
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Applying ISO 10993-1 to Medical Device Submission to FDA
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What is a Class 2 Medical Device in the US?
Blog

Top Risk Management Tools in the Medical Device Industry
Blog

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

Best Practices for eConsent in Medical Device Clinical Investigations
Blog

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

What is 21 CFR 812 - Investigational Device Exemption?
Blog

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

Implementing an eQMS after Switching from Paper
Blog

Greenlight Guru Announces 2023 True Quality Roadshow
Blog

Greenlight Guru Releases 2023 MedTech Industry Benchmark Report
Blog

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

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

Essentials of Sterilization for Med Device Professionals
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The Essential Guide to eCRF (Electronic Case Report Form) for Medical Devices
Blog

The Medical Device Development Process: A Deep Dive into the 5 Phases
Podcast

UDI: 101
Blog

How to Plan a Clinical Data Management Setup for EDC Systems
Podcast

Quality Myths and Lessons Learned
Blog

Greenlight Guru Announces Partnership with Comply Guru
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Understanding FDA Cleared vs Approved vs Granted for Medical Devices
Blog

Explaining the Role of PRRC under MDR & IVDR: Your Questions Answered
Blog

9 Steps to Creating a CAPA Audit Checklist
Podcast

Determining User Needs for Your Medical Device
Blog

The 3 C’s of the EU MDR: Changes, Challenges and Contributions
Podcast

Fraud in the Healthcare Industry & the Role of Whistleblowers
Blog

GUDID 101: Everything You Need to Know About FDA’s Global Unique Device Identification Database
Blog

How to Manage the Different CAPA Phases
Podcast

Auditing the Auditor
Podcast

What is MedTech Lifecycle Excellence?
Blog

What is an ISO Audit?
Blog

Tips for Structuring Your Internal Audit Program (and Mistakes to Avoid)
Blog

Medical Device Clinical Trials: Regulatory Pathways & Study Types Explained
Blog

5 Steps For Effective Trial Design and Improved Compliance
Podcast

The Best of Jon & Mike Through the Years
Blog

How to Verify and Validate SaMD in Different Stages
Blog

Most Popular Medical Device Content in 2022
Blog

Optimizing Generation of Clinical Evidence for Medical Devices
Podcast

CDRH Proposed Guidance for FY 2023
Blog

Randomization in Medical Device Clinical Trials: Everything You Need to Know
Blog

A Year of Scale, Support, and Celebration
Blog

Design Controls Need to Start With User Needs
Blog

The Importance of Management Reviews for CAPAs
Blog

CAPA Best Practices: 4 Tips for Building an Excellent CAPA Process
Blog

How Technology Can Support Clinical Trial Continuity & Data Integrity
Podcast

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

Greenlight Guru Hits the 1,000 Customer Milestone
Blog

A Letter From the CEO: Celebrating 1,000 Medical Device Customers
Blog

How to Use Greenlight Guru Clinical's ePRO Module
Blog

Electronic Data Capture for Medical Devices: Then vs. Now
Blog

Greenlight Guru Appoints Dan Thompson as Chief Sales Officer and Jeff Perkins as Chief Marketing Officer
Podcast

The Future of Healthcare & How We Get There
Blog

How to Switch to eQMS Software When You're Just Using Paper
Blog

How ePRO Can Help Comply with EU MDR Post-Market Surveillance
Blog

The Difference Between Intended Use and Indications of Use (And Why These Statements Are So Important)
Blog

Nonconformance (NC) and CAPA: When Should You Use Each Process?
Podcast

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

Tracking Serious Adverse Events for Medical Devices (to Ensure GCP Compliance)
Podcast

Developing a Regulatory Strategy
Blog

What Device Makers Need To Know About Design Verification and Validation
Blog

Understanding Root Cause Analysis in the CAPA Process
Blog

How Does the EU GDPR Impact Medical Device Clinical Trials?
Podcast

We Achieved ISO Certification! Now what?
Blog

How to Integrate Complaint Handling and Risk Management
Blog

8 Tips Before Calculating Sample Size in Medical Device Clinical Studies
Podcast

The Future of Reprocessed Used Medical Equipment
Blog

The Difference Between Managing Product & Services Suppliers in MedTech
Podcast

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

MDCG Guidance Documents Overview on Clinical Investigations and Evaluations
Podcast

Customer Discovery for Medical Device Companies
Blog

Why Investigator Initiated Studies Alone Are Not the Solution for PMCF Under EU MDR
Podcast

EUA and the Impending Transition
Blog

Approved Supplier List: How To Add Suppliers to Your ASL in 7 Steps
Blog

3 Common Misconceptions About Medical Device Labeling
Blog

Medical Device QMS + Guru MedTech Experts: A Winning Combo for Global Market Success
Blog

10 Best Practices for eCRF in Medical Device Trials
Podcast

Common QMS Mistakes SaMD Companies Make
Blog

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

How to Integrate UDI into a Quality System for Your Medical Device
Blog

Should ISO 15189 Certification Matter to Medical Device Companies?
Blog

Basic UDI-DI: What is it and How to Assign it for Your Medical Device
Blog

Guidance on How to Conduct Clinical Investigations Under EU MDR
Podcast

Design Assurance: The Unsung Heroes of R&D
Blog

What You Need to Know About Risk Management and Using Post-Market Data
Blog

MDCG 2020-5 Explained: How To Demonstrate Equivalency in the EU
Blog

Computer Software Assurance for Medical Devices: What Does FDA’s Draft Guidance Mean for You?
Podcast

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

Get Compliant Clinical Data with Investigator-Initiated Studies
Blog

Preparing for EUDAMED - Europe’s Medical Device Database
Blog

The Medical Device Practical Guide to PMCF Requirements under EU MDR
Blog

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

3 Tips For Incorporating Risk Management During Medical Device Product Development
Blog

10 Tips for Selecting the Right EDC Software for Clinical Investigations
Podcast

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

Four Years, For You
Blog

15 Steps to Getting Approval for IEC 60601-1
Blog

IEC 82304 vs IEC 62304: Software Standards for SaMD Explained
Podcast

How Proper Design Controls & a Quality System Could Save You $20M With Ronny Bracken
Blog

Compliant Adverse Event Reporting in Clinical Studies under the EU MDR
Podcast

Best Practices for Clinical Evidence Management
Blog

What You Need to Know About Medical Device Software Validation
Blog

MEDDEV 2.7/1 Rev. 4 & MDCG Guidance: Carrying Out Clinical Evaluation Under EU MDR
Blog

eCRF Template for Clinical Investigations and PMCF Studies
Podcast

Building Your Regulatory Strategy for Commercialization
Blog

AAMI TIR45: Closing the Gap Between Agile Software Development & Medical Device Regulations
Blog

MDCG 2020-6 Explained: Sufficient Clinical Evidence for Legacy Medical Devices in the EU
Podcast

Packaging Validation Best Practices
Blog

Failure Mode Effects Analysis: What Is It & When Should You Use It?
Blog

Explaining MDCG 2019-11: Software Qualification & Classification for MDR & IVDR
Blog

Bill of Materials (BOM) for Medical Devices: Everything You Need To Know
Podcast

Overcoming Submission Deficiencies due to Biocompatibility
Blog

Understanding FDA’s Special 510(k) Program
Blog

How to Communicate Your Regulatory Strategy to Medical Device Investors
Blog

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

Does Your CAPA Process Need a CAPA?
Blog

How the Design Control Process Applies to a 510(k) Premarket Notification
Blog

How to Use Queries for Monitoring Medical Device Studies in Greenlight Guru Clinical
Podcast

UDI and the Current State of Global Implementation
Blog

Ultimate Guide to UDI for Medical Devices
Blog

Why Class 1 Medical Device Companies Need Design Controls (even if it’s not required)
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