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Blog

Carrying out a supplier audit: when and how to audit your suppliers
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Turn your PMCF activities into a competitive advantage
Blog

The 5 key elements of an effective CAPA system
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Welcome Ultralight Labs to Greenlight Guru
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The future of EU MDR: insights and strategies for 2025 (free eBook)
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FDA Guidances on AI-Enabled Devices: Where AI Stands in 2025
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The 5 most common clinical data pitfalls in 2025 (and how to avoid them)
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Facing uncertainty: how medical device companies are navigating the current economic conditions
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Introducing Document Comparison: Boost Audit Readiness, Accelerate Training, and Streamline Approvals
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Clinical Trials in 2025: The Outlook for Medical Device Companies
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What’s New in Greenlight Guru Clinical 2025.1: Smarter Show Rules and Easier File Vault Access
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The Biggest Quality Challenges for Medical Device Companies in 2025
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5 Common Regulatory Pitfalls in the Medical Device Industry (and How to Avoid Them)
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11 Questions to Ask QMS Software Vendors in the Medical Device Industry
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2025 Medical Device Industry Report: Quality Challenges, Regulatory Complexity, and Economic Uncertainty
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Notification of a Manufacturing Discontinuance or Interruption: Does the FDA’s Guidance Apply to You?
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Notification of a Manufacturing Discontinuance or Interruption: Does the FDA’s Guidance Apply to You?
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3 Insights on MedTech Product Development from an Ex-FDA Investigator
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Best QMS Software: Ultimate Guide to Comparing Quality Management System Solutions
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How to Create a Quality Manual per ISO 13485 (Plus Free Template)
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How to Build Your Own GSPR Checklist (Plus Free Template)
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Improving Clinical Data Collection with Effective eCRF Completion Guidelines
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How to Use an FMEA Template as Part of Your Medical Device Risk Management
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Developing a PMCF Plan: Your Blueprint for Regulatory Compliance
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3 Key Steps for Supplier Risk Assessment in MedTech
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Navigating FDA Guidance on Electronic Systems, Records, and Signatures in Clinical Investigations: A Comprehensive Overview for Medical Device Companies
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Most Popular Medical Device Content in 2024
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Top Medical Device Conferences To Attend in 2025
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QMS Implementation: The Key Steps and Tips for Implementing an eQMS
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Creative Clinical Recruitment: 4 Steps to Overcome Barriers to Participation
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Medical Device Compliance: Regulations, Standards, and Solutions
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Enhanced Consenting Options for Clinical Studies
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5 mistakes to avoid when seeking funding for your medical device
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The FDA Medical Device Approval Process: Pathways, Timelines, and Tips
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FDA's Predetermined Change Control Plan: What's in the New Draft Guidance
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Quality Management Consulting: How and When to Seek Help
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Building an Effective CAPA Program: Key Steps and Common Challenges
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SaMD software documentation: 7 must-haves for premarket submissions
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Medical Device QMS + Guru MedTech Experts: A Winning Combo for Global Market Success
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Why Your Company Needs a QMS Software or eQMS
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Market Access vs Adoption: Why Your Class II Device Needs Clinical Evidence
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Case Study: How a Partnership with Greenlight Guru is Making This Dental Device Manufacturer Smile
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Real-World Data and Real-World Evidence: When and How to Use Them
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Ultimate Guide to In Vitro Diagnostic (IVD) Devices
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A Free CAPA Template for the Medical Device Industry
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7 Steps to Respond to FDA 483 Inspection Observations (Response Template Included)
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Cybersecurity for Medical Devices: Best Practices from Regulatory Standards
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Strategies for Successful PMA Submissions: A Guide for Clinical Teams
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Top 100 Medical Device Acronyms & Terminology You Need to Know
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QMSR Explained: What FDA QSR & ISO 13485 Harmonization Means for Medical Device Companies
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First-In-Class Diagnostics Tool Gets 510(k) Clearance Thanks to Greenlight Guru's QMS Software
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How to Set Up Clinical Studies to Comply with US FDA Regulations
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5 Elements that Must Connect to Your Design Controls for an Audit-Proof QMS
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Going from Weeks to Hours of Audit Prep Time for Easy ISO 13485 Certification
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Post-Market Surveillance for Medical Devices & IVDs: Requirements & Proactive Data Collection
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Data Management and Reporting in FDA-Regulated Clinical Trials
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Biocompatibility Testing for Medical Devices 101
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Direct to Consumer - The Future of Healthcare
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How 4 Pre-Market MedTech Companies are Leveraging Greenlight Guru Quality
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Quality Management Audit or Assessment? The Differences Explained
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A Guide to Bridging User Needs Into Design Requirements
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ISO 13485 and FDA QSR: A Step-by-Step Guide to Complying with Medical Device QMS Requirements
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MDR and IVDR: Challenges and Opportunities of the New Regulations
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Paper Systems Are the Riskiest Way to Manage Medical Device Projects
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6 Medical Device Product Development Steps To Fast-Track Your Path To Market
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LDT Enforcement Discretion Phaseout: What You Need to Do in the First Year
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2024 Greenlight Guru True Quality Roadshow: Copenhagen Recap
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Why FMEA is Not ISO 14971 Risk Management
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How to Define Your Design Inputs and Design Outputs
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How to Carry Out PMCF Activities According to EU MDR
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FDA Issues LDT Final Rule to Regulate Laboratory Developed Tests as IVD Devices
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QMSR & the End of DMR, DHR, DHF: How FDA’s New Rule Impacts Record-Keeping
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3 Types of QMS Audits (Plus 3 Tips to Prepare for Them)
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FDA’s PMA Supplements and Amendments: When and How to Use Each
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Design History File (DHF) vs. Device Master Record (DMR) vs. Device History Record (DHR): What's the Difference?
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IQ, OQ, PQ: A Quick Guide to Process Validation (Plus Free Resources)
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MDCG 2024-5: Guidance on the Investigator’s Brochure Explained
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Beginner's Guide to Design Verification & Design Validation for Medical Devices
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Ultimate Guide to Device Class Requirements under EU MDR
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Entering the Australia & New Zealand Markets: What Medical Device Manufacturers Need to Know
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QMS Principles for Software As a Medical Device (SaMD) Manufacturers
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Here Are the 4 Types of FDA Inspections You Need to Understand
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ISO 14971 Risk Management for Medical Devices: The Definitive Guide
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How are Medical Devices Classified under EU MDR?
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MDCG 2024-3: What the Latest Guidance on Clinical Investigation Plans (CIP) Tells Us
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The Risk Management + Design Controls Connection: What Device Makers Need to Know
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Definitive Guide to Change Management & Change Control for Medical Devices
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Top 50 Medical Device Product Design and Development Companies
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Ultimate Guide to Clinical Data Management in MedTech
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FDA 510(k) Submission Process: A Step-By-Step Guide On How To Prepare Yours
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What is a Class III Medical Device in the US?
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Improving Study Management in MedTech with Greenlight Guru Clinical’s Custom Collaborator Roles
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Greenlight Guru Shines in G2 Spring 2024 Report, Dominating in Medical QMS and EDC Categories
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Meeting Timelines and Managing Budgets - Best Practices for MedTech Clinical Investigations
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FDA Medical Device Classifications - How To Determine Your Device Class
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ISO 13485: Ultimate Guide to Medical Devices QMS
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Step-by-Step Guide to FDA PMA Submissions for Class III Medical Devices
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How to Take Control of Training Management and Stay Compliant with ISO 13485:2016 and Part 820.25
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Ready to Submit Your FDA 510(k)? But Wait, There's No Human Factors!
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The Ultimate Guide To Design Controls For Medical Device Companies
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Quality Management Plan - How to Create Yours (Tips & Best Practices)
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How to Structure your Medical Device Technical File
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Adopting AI in Quality Management: Practical Solutions for the MedTech Industry
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Outsourcing Clinical Activities in 2024: Choosing A CRO
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Quality Assurance (QA) vs. Quality Control (QC) in the Medical Device Industry
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ALM and Design Controls: Do SaMD and SiMD Manufacturers Need Both?
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How MHRA is Regulating Medical Devices in the UK after Brexit
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Investigator Initiated Studies — 3 Common Problems and How to Fix Them
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5 Habits of Highly Effective MedTech Companies
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Case Study: How Delta Development Fast-tracked R&D Down to 1 Year by Implementing a Medical Device QMS
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How to Use the Turtle Diagram for Better Internal Audits
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Greenlight Guru Announces the 2024 True Quality Roadshow
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Clinical Data Collection - 7 Key Pitfalls To Avoid In MedTech
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FDA Publishes Final Rule on QMSR
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Introducing Risk Reviews for Efficient, Compliant Risk Management
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Calculating Nonconformance Costs in the MedTech Industry
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Selecting a Notified Body: How to Work with Your New Device Authority
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Greenlight Guru Finishes 2023 with Strong Momentum in Q4
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IVDR: How to Meet the Quality Management System Requirements of a Device
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Navigating Clinical Evaluations and Investigations in MedTech
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How PLM and QMS Solutions Work Together in MedTech
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Guide to Managing Your Medical Device on the Market and Scaling Manufacturing
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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
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Most Popular Medical Device Content in 2023
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Moving MedTech Forward: Greenlight Guru’s 2023 in Review
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Top 40+ Medical Device Contract Research Organizations (CROs)
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Electronic Data Capture (EDC) Buyer’s Guide: Making the Business Case for a New EDC System
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AI, Automation, and Risk in MedTech
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A Better Way to Develop a Medical Device with Digital and Physical Elements (Part 1 of 2)
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A Better Way to Develop A Medical Device with Digital and Physical Elements (Part 2 of 2)
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The Ugly Truth About Managing Design Controls on Spreadsheets
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Enterprise Quality Management System Software: What You Need To Know
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Ultimate Guide to Supplier Management for Medical Device Companies
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Greenlight Guru Releases The AI in MedTech Trend Report 2023
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The AI in MedTech Trend Report 2023 Is Here
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How to Master the CAPA Process: Complete Guide with Visual
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Benefits of Switching from MasterControl to Greenlight Guru
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Reducing Medical Device Risk with Usability Testing: The Why, the How, and the Who
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Ultimate Guide to Software as a Medical Device (SaMD)
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Top 7 QMS Tools for MedTech (Plus 4 Bonus Resources)
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Ultimate Internal Audit Checklist: FDA QSR & ISO 13485 Audit Checklist
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Greenlight Guru Expands Market Leadership with Strong Momentum in Q3 2023
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IVDR for In Vitro Diagnostic Medical Device Companies - Ultimate Guide
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5 Foundational Steps of a CAPA Quality Process
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Ultimate Guide to Corrective and Preventive Action (CAPA) for Medical Devices
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EU MDR - 9 Top Questions Answered (European MDR)
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Passing MDSAP Audit & Getting FDA Approval Just Weeks After Implementing Greenlight Guru Quality
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FDA Proposes New Rule to Regulate LDTs as IVDs: Here’s What’s at Stake
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23 Must-haves for your Product Requirements Document (Free Checklist + Guide)
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MHRA Guidance Document on Clinical Investigations in UK
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Guide to Understanding AI Applications that Drive Business Value in MedTech
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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
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Ultimate Guide to ISO 14155:2020 for Medical Devices
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How To Approach Supplier Corrective Action Requests (SCAR)
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5 Tips for Medical Device Registration across Global Markets
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Engineering Change Order: Its Role in the Change Management Process
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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
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Creating a Supplier Scorecard for Medical Device Supplier Management
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What is a Predetermined Change Control Plan (PCCP) and Who Needs One?
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3 Tips for Adding Flexibility to Your MedTech Manufacturing Supply Chain
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What is the FDA Medical Device Registration Process?
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Machine Learning, AI and Risk Management: TIR34971 Explained
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How to Comply with HIPAA and EU GDPR in Medical Device Studies
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Greenlight Guru Invests in State-of-the-Art Arena and Training Facility That Aims to Help Youth Basketball Players On and Off the Court
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Conducting Quality Investigations in Medical Device Manufacturing
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Omnibus Act Impact on Medical Device Cybersecurity
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Boost Efficiency and Decision-Making with Enhanced Clinical Data Reporting
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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
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Ultimate List of ISO Standards for Medical Devices
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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
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Centese Trades in Paper-based QMS for Greenlight Guru Quality & Achieves 510(k) Clearance
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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
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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
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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
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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
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What is a Modern QMS?
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4 Tips for Managing Your MedTech Portfolio
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How To Use FDA’s Guidance on Post-Approval Studies During Premarket Approval
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2023 Greenlight Guru True Quality Roadshow: San Jose Recap
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How To Vet Medical Device Distributors in Multiple Markets
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What is the Best Way to Structure a Risk Management File?
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7 Tips for FDA 21 CFR Part 11 Compliance
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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
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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
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Planning Your Medical Device Global Market Regulatory Strategy
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Why Clinical Data Is Essential to Value-Based Healthcare
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3 Things to Love about Internal Audits
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HTEC Group Partners with Greenlight Guru to Accelerate Time-to-Market for Medical Device Companies
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4 Advantages of an eQMS Over a Paper-Based QMS
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How to Use Clinical Data in Medical Device Submissions in the EU & US
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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
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How To Avoid a Failed QMS Implementation
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5 Steps for Getting your CE Marking with EU MDR Requirements
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2023 Greenlight Guru True Quality Roadshow: Houston Recap
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Can dFMEA and ISO 14971 Co-Exist in Medical Device Risk Management?
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“A Perfect eQMS”: Customers Rank Greenlight Guru #1 QMS in G2 Spring 2023 QMS Grid Report
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ePRO vs Paper: The Debate Over Patient Reported Outcomes Is Over
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Greenlight Guru Introduces Export API for a Connected Quality Management System
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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
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Electronic Data Capture Systems vs. Paper-based Data Collection
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How to Handle Medical Device Adverse Events
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Explaining IVDR Classification for In Vitro Medical Devices
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Create Your GTM Strategy: The Complete Guide to Bringing a Medical Device to Market
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Making the BOM & Design Controls Connection
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Case Study: How IVD Manufacturer Streamlined Production and Improved Quality Processes with an Industry-Specific QMS
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Clinical Data Management System (CDMS) for Medical Device Clinical Trials
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Everything You Need to Know About Electronic Data Capture (EDC) for Clinical Trials
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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
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Good Clinical Practice (GCP) Compliance in Clinical Data Collection
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Comprehensive 21 CFR Part 11 Guide: Requirements and Downloadable Resources
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Research shows eCRFs faster, more reliable than paper CRFs
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How to Define User Needs During Design Controls
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Greenlight Guru Introduces Newly Expanded Global Partner Program
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Does My Device Labeling Comply with 21 CFR 801?
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Utility Patent vs Design Patent: Choosing the Right One for Your Device
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Ultimate Guide to Postmarket Surveillance of Medical Devices
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How to Write a Nonconformance Report in 7 Steps
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How to Choose an Electronic Data Capture System to Comply with EU MDR
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Switching to an Electronic Device History Record (eDHR): What Medical Device Companies Should Know
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What is a Class 1 Medical Device?
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FDA Human Factors Guidance Draft: What Medical Device Manufacturers Need to Know
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3 Factors that Impact Application of Decentralized Clinical Investigations for Medical Devices
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Top 100 Medical Device Companies (Free Chart Included)
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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
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21 CFR Part 820: Ultimate Guide to FDA's Quality System Regulation (QSR) for Medical Devices
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What is a Document Control System for Medical Devices?
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The Pitfalls of Using Paper and Excel for Clinical Data
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How to use eConsent Efficiently in Medical Device Studies
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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 an FDA Class 2 Medical Device in the US?
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Top Risk Management Tools in the Medical Device Industry
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Process Verification vs Process Validation: What’s the Difference?
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Best Practices for eConsent in Medical Device Clinical Investigations
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FDA Form 483 Observations and FDA Warning Letters - What’s the Difference?
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What is 21 CFR 812 - Investigational Device Exemption?
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Creating a Periodic Safety Update Report (PSUR) that Complies with MDR & IVDR
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Greenlight Guru Announces 2023 True Quality Roadshow
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Greenlight Guru Releases 2023 MedTech Industry Benchmark Report
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Computer Systems Validation: How To Avoid FDA Warning Letters C.F.R. 820.70(i)
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How to Collect PMCF Data for Lower-Class Medical Devices and WETs
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The Essential Guide to eCRF (Electronic Case Report Form) for Medical Devices
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The Medical Device Development Process: A Deep Dive into the 5 Phases
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How to Plan a Clinical Data Management Setup for EDC Systems
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Greenlight Guru Announces Partnership with Comply Guru
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Understanding FDA Cleared vs Approved vs Granted for Medical Devices
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Explaining the Role of PRRC under MDR & IVDR: Your Questions Answered
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9 Steps to Creating a CAPA Audit Checklist
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The 3 C’s of the EU MDR: Changes, Challenges and Contributions
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GUDID 101: Everything You Need to Know About FDA’s Global Unique Device Identification Database
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How to Manage the Different CAPA Phases
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What is an ISO Audit?
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Tips for Structuring Your Internal Audit Program (and Mistakes to Avoid)
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Medical Device Clinical Trials: Regulatory Pathways & Study Types Explained
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5 Steps For Effective Trial Design and Improved Compliance
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How to Verify and Validate SaMD in Different Stages
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Most Popular Medical Device Content in 2022
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Optimizing Generation of Clinical Evidence for Medical Devices
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Randomization in Medical Device Clinical Trials: Everything You Need to Know
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A Year of Scale, Support, and Celebration
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Design Controls Need to Start With User Needs
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The Importance of Management Reviews for CAPAs
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CAPA Best Practices: 4 Tips for Building an Excellent CAPA Process
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How Technology Can Support Clinical Trial Continuity & Data Integrity
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Greenlight Guru Hits the 1,000 Customer Milestone
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A Letter From the CEO: Celebrating 1,000 Medical Device Customers
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How to Use Greenlight Guru Clinical's ePRO Module
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Electronic Data Capture for Medical Devices: Then vs. Now
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Greenlight Guru Appoints Dan Thompson as Chief Sales Officer and Jeff Perkins as Chief Marketing Officer
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How to Switch to eQMS Software When You're Just Using Paper
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How ePRO Can Help Comply with EU MDR Post-Market Surveillance
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The Difference Between Intended Use and Indications of Use (And Why These Statements Are So Important)
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Nonconformance (NC) and CAPA: When Should You Use Each Process?
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Tracking Serious Adverse Events for Medical Devices (to Ensure GCP Compliance)
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What Device Makers Need To Know About Design Verification and Validation
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Understanding Root Cause Analysis in the CAPA Process
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How Does the EU GDPR Impact Medical Device Clinical Trials?
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How to Integrate Complaint Handling and Risk Management
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8 Tips Before Calculating Sample Size in Medical Device Clinical Studies
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The Difference Between Managing Product & Services Suppliers in MedTech
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MDCG Guidance Documents Overview on Clinical Investigations and Evaluations
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Why Investigator Initiated Studies Alone Are Not the Solution for PMCF Under EU MDR
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Approved Supplier List: How To Add Suppliers to Your ASL in 7 Steps
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3 Common Misconceptions About Medical Device Labeling
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10 Best Practices for eCRF in Medical Device Trials
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15 Steps to Getting Approval for IEC 60601-1 (Staging)
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How to Integrate UDI into a Quality System for Your Medical Device
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Should ISO 15189 Certification Matter to Medical Device Companies?
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Basic UDI-DI: What is it and How to Assign it for Your Medical Device
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Guidance on How to Conduct Clinical Investigations Under EU MDR
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What You Need to Know About Risk Management and Using Post-Market Data
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MDCG 2020-5 Explained: How To Demonstrate Equivalency in the EU
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Computer Software Assurance for Medical Devices: What Does FDA’s Draft Guidance Mean for You?
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Get Compliant Clinical Data with Investigator-Initiated Studies
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Preparing for EUDAMED - Europe’s Medical Device Database
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The Medical Device Practical Guide to PMCF Requirements under EU MDR
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What is a Quality Culture? (and 7 Tips for Creating One)
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3 Tips For Incorporating Risk Management During Medical Device Product Development
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10 Tips for Selecting the Right EDC Software for Clinical Investigations
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Four Years, For You
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15 Steps to Getting Approval for IEC 60601-1
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IEC 82304 vs IEC 62304: Software Standards for SaMD Explained
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Compliant Adverse Event Reporting in Clinical Studies under the EU MDR
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What You Need to Know About Medical Device Software Validation
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MEDDEV 2.7/1 Rev. 4 & MDCG Guidance: Carrying Out Clinical Evaluation Under EU MDR
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eCRF Template for Clinical Investigations and PMCF Studies
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AAMI TIR45: Closing the Gap Between Agile Software Development & Medical Device Regulations
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MDCG 2020-6 Explained: Sufficient Clinical Evidence for Legacy Medical Devices in the EU
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Failure Mode Effects Analysis: What Is It & When Should You Use It?
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Explaining MDCG 2019-11: Software Qualification & Classification for MDR & IVDR
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Bill of Materials (BOM) for Medical Devices: Everything You Need To Know
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Understanding FDA’s Special 510(k) Program
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How to Communicate Your Regulatory Strategy to Medical Device Investors
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How to Design an Electronic Case Report Form (eCRF) for Medical Device Studies
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How the Design Control Process Applies to a 510(k) Premarket Notification
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How to Use Queries for Monitoring Medical Device Studies in Greenlight Guru Clinical
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Ultimate Guide to UDI for Medical Devices
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Why Class 1 Medical Device Companies Need Design Controls (even if it’s not required)
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How to Calculate Sample Size for Medical Device Studies
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What are the Risk Management Documentation Requirements of ISO 14971?
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Why is Post-Market Surveillance Important for Medical Devices?
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Why Training Compliance Matters for Pre-Market MedTech Companies
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3 Common Problems with Design Controls (and the Solutions)
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Downstream Effects of Inadequate Complaint Handling
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What are the Distributor Requirements under EU MDR and IVDR?
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Greenlight Guru Further Extends Commitment to Quality for Customers with Earning Both ISO 9001 and ISO 27001 Certifications
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Selecting The Ideal PMCF Activity
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3 Tips for Managing Your Medical Device Design History File
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Understanding The Relationship Between Usability and Labeling of Your Medical Device
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How To Apply a Risk-Based Approach to Biological Evaluation
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4 Letter to File Mistakes That Could Cost You
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Striving for Excellence: G2 Ranks Greenlight Guru #1 in Best Support, Best Usability, and Best Results for QMS
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Understanding Change Management and Change Control in the Medical Device Industry
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Medical Device Companies - Top 100 in 2020 (Free Chart) (Clone)
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3 Stages of Project Management in the Medical Device Industry & How to Navigate Each
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Greenlight Guru Unveils the World's First MedTech Lifecycle Excellence Platform to Enable Success Across The Entire Product Lifecycle
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MedTech Lifecycle Excellence: Out of the Dark and into the Age of Enlightened Quality
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Recap of True Quality 2022
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What Role Should Quality Play in Bringing a Medical Device to Market?
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Who are the Economic Operators & What Does EU MDR Require of Them?
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Applying for International Patents as a Medical Device Company
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Greenlight Guru Acquires Electronic Data Capture Solution SMART-TRIAL
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5 Strategies to Limit Project Timeline and Cost for your Medical Device
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Setting up a Clinical Investigation under EU MDR
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Greenlight Guru Acquires AI/ML Consultancy Vertex Intelligence
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Greenlight Guru Academy Advance: The Future of MedTech Learning is Continuous
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How to Build a Medical Device Business Case in 5 Easy Steps
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FDA De Novo Pathway: Process Explained for Medical Device Companies
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Greenlight Guru Earns 2022 TrustRadius Top Rated Software Award
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8 Questions That Define Your Medical Device User Needs
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7 Tips to Attract Investors and Raise Funds for your Medical Device
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Performance Evaluation Under EU IVDR: Proving Your IVD’s Performance
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30/60/90 Day Plan to Making an Impact as a New QA/RA Manager
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3 Tips for Planning a Successful Product Development Project for Your Medical Device
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How to Make the Most of True Quality 2022
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Explaining UDI Requirements for GUDID and EUDAMED
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Ultimate Guide to Clinical Evaluation of a Medical Device in the EU
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How to Streamline the Customer Complaint Handling Process
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3 Common Misconceptions About Medical Device Packaging
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30/60/90 Day Plan to Making an Impact as a Product Development Engineer
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How to Create a Clinical Evaluation Report (CER) under MEDDEV & MDR (Part 4 of 4)
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Performing Data Analysis for Your Medical Device’s Clinical Evaluation (Part 3 of 4)
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Everything You Need to Know About Root Cause Analysis
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The Clinical Evaluation Literature Review Process: Identifying and Appraising Clinical Data (Part 2 of 4)
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Greenlight Guru Consistently Ranked as a Trusted Partner for Leading Medical Device Companies
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Clinical Evaluation of a Medical Device: Creating a Process and Establishing Equivalency (Part 1 of 4)
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4 Problems (and Solutions) for the Medical Device Supply Chain
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FDA Inspections and ISO Audits: What is the Difference?
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Understanding Technical Documentation in EU Regulations
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Let The Document Tell The Story: Document Management Best Practices
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Your Device is Non-Significant Risk: Now What?
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The Five Themes of True Quality 2022
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Greenlight Guru and Lexisnexis® Reed Tech Announce Strategic Alliance to Guide Customers to Market Faster
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Software Bill of Materials: What to Know About SBOMs for Medical Devices
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Survey Finds Fewer Than 3% of Pre-Market Medical Device Companies Are Very Effective at Measuring the Results of Quality Initiatives
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How to Convince Your Boss to Send You to True Quality 2022
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Greenlight Guru Expands Solution to Further Integrate Quality and Product Development Activities
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Achieve Connected & Continuous Product Development: Introducing Greenlight Guru Products
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What Should Really Trigger a CAPA?
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10 Reasons to Attend True Quality 2022
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What You Need to Know About True Quality 2022
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Greenlight Guru Announces True Quality 2022, Inaugural Conference for the Medical Device Industry
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3 Medical Device Security Challenges (and Solutions)
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How Do FDA Medical Device Recalls Work?
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The Definitive Guide to Responding to FDA 483 Observations and Warning Letters
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Understanding the Quality Control Process in Medical Device Manufacturing
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ISO 11137: An Introduction to Gamma Sterilization Validation
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Best Practices for an Effective Medical Device Design Transfer Process
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Most Popular Medical Device Content in 2021
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Cytotoxicity Testing: Ensuring the Biocompatibility of Your Medical Device
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Customers Rank Greenlight Guru As Leading QMS Software on G2 For 13th Consecutive Quarter
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Understanding Product Realization under ISO 13485:2016
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UDI: Everything You Need to Know About Unique Device Identifiers for the FDA
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What Does the IDE Application Process Involve?
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Tips for Virtual Audits Your Medical Device Company Can Implement Today
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Key Actions for Effective Medical Device Customer Complaint Handling
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ISO 11607: A Primer on Packaging for Terminally Sterilized Medical Devices
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Transitioning to IVDR: The New EU Regulation for In Vitro Diagnostic Medical Devices
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Greenlight Guru Launches Guru Assist, On-Demand Lifeline to Medical Device Experts
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15 Items Medical Device Startups Need to Address
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ISO 11135: An Overview of Medical Device Sterilization Using Ethylene Oxide
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The Growing Internet of Medical Things (IoMT) & its Implications for Medical Device Manufacturers
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3 Non-negotiables for Managing Business Risk as a Medical Device Company
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What are the SaMD Requirements from FDA?
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Greenlight Guru and Formlabs Partner to Mitigate Risk and Accelerate Product Development in order to Improve Patient Outcomes
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Competent Authority, Notified Body, ISO Registrar: How Each Role Functions in the Medical Device Industry
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25 FAQs (& Answers) about ISO 15223-1:2021 Fourth Edition
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7 Project Management Tips
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Clinical Evaluation vs. Investigation: Everything You Need to Know
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IEC 62366 Explained: What You Need To Know About Usability Engineering
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Medical Device 3D Printing: Should You Make the Move?
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Clinical Testing for Medical Devices: What US Manufacturers Need to Know
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Ultimate Guide to QA & RA in Medical Device 3D Printing
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Choosing an EU Authorised Representative (EC REP) for Medical Device Regulatory Issues
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Software as a Medical Device: Definitions, Examples & Regulatory Framework
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European Authorized Representative for Medical Device Companies
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3 FAQ about CE Marking Medical Device Manufacturers Want to Know
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How to Execute a Successful Product Launch
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Case Study: How The Partner Ecosystem Has Been Key To Market Success For Spark Biomedical
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Greenlight Guru Opens New Global Headquarters in Downtown Indianapolis
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How Should Artificial Intelligence in Medical Devices be Regulated?
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3 Medical Device Reimbursement Strategies to Recoup Your Investment in the US
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Debunking 4 Commonly Held Design Control Myths
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How to Assess the Impact of Any Change to your Medical Device (+ Free Checklist)
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Top 3 Reasons for FDA 483 Observations in 2020
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How to Use the MDSAP Companion Document
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ISO 20417:2021 Replaces EN 1041: What You Need To Know
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Driving MedTech Innovation with Safe and Effective Medical Devices
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5 Biggest Quality Mistakes (And How You Can Avoid Making Them)
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CEO of High-Growth Software Company Places Top 10 in the World in Elite Rowing Competition
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5 Postmarket Surveillance System Musts for Every EU Manufacturer
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3 Things Med Device Startups Must Do When Implementing a QMS
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3 Life[cycle] Hacks for Integrating Risk Management throughout all Device Phases
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Understanding the Premarket Approval (PMA) Process
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How to Apply IEC 62304 Requirements for Medical Device Software
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Understanding the FDA Medical Device Classification System
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Choosing and Managing Your Medical Device Suppliers
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Understanding Intended Use from ISO TR 24971:2020
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How the MDSAP Grading System Works
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Greenlight Guru Announces Medical Device HQ Partnership
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Greenlight Guru Receives Strategic Growth Investment from JMI Equity
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Recruiting Top Medical Device Talent in a Competitive Market
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Crash Course on Greenlight Guru Academy: How Medical Device Professionals Stay Ahead
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FDA QSR Transition to ISO 13485: Is Global Regulatory Harmonization on the Horizon?
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Greenlight Guru Announces the Formation of Its New Regulatory Advisory Board
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5 Tips to Improve your Medical Equipment Quality Assurance Activities
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Answer These 3 Questions Before Developing Software as a Medical Device
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How to Make Your QMS Comply with EU MDR and IVDR
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4 Reasons to Get ISO 27001 Certification
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Three Tips for Designing At-Home Monitoring Devices that Deliver Actionable Information
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How to Build Medical Device Usability Testing and Validation into Your Quality System
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Preparing Your Abbreviated 510(k) Submission in 7 Easy Steps
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5 Steps to Faster-to-Market, More Profitable Medical Devices
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Greenlight Guru Named Premier QMS Software for NIH RADx Initiative
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What is a Quality Agreement for Medical Devices?
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FDA Medical Device Labeling Requirements: Are You Complying?
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How to Use the FDA ESG (Electronic Submissions Gateway)
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3 Valuable Outcomes of a Culture of Quality
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What is a Traceability Matrix and How Do I Create One for My Medical Device?
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Greenlight Guru Launches Greenlight Guru Academy as a Trusted Source of Education to the Global Medical Device Community
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How to Demonstrate Substantial Equivalence in 5 Easy Steps
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How to Use Voluntary Consensus Standards to your Strategic Advantage
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Special 510(k) vs. Abbreviated 510(k) vs. Traditional 510(k): Which FDA Program Applies to My Device?
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5 Ways to Leverage Internal Quality Audits to Improve External Audit Outcomes
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Greenlight Guru Announces True Quality Summit Series: EU MDR & IVDR
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Ultimate Guide to Training Management for Medical Device Companies
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Understanding ISO 13485 Training and Competency Requirements
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5 Key Principles of Total Quality Management
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How Does a Medical Device Quality Management System Differ from other QMS Tools?
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Submitting a 510(k)? First Make Sure You Know What 'Substantial Equivalence' Means
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Change Management Process Explained in 6 Easy Steps (+ free template)
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How to Use the De Novo Pathway for your Medical Device
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Greenlight Guru and Nelson Labs Announce Strategic Alliance to Mitigate Risk and Guide Customers to Market Faster
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Most Popular Medical Device Content in 2020 from Greenlight Guru
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6 Benefits of the Best 21 CFR Part 11 Compliant Software
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2021 State of Medical Device Quality Management and Product Development Benchmark Report
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What is the True Cost of Poor Quality for Your Medical Device Company? (Free Infographic)
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12 Medical Device Experts Offer Best Tips for How to Succeed in 2021
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Top 100 Medical Device Startups with Most Money Raised in 2020 (Free Chart)
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Streamline the right training, for the right people, at the right time. Introducing Greenlight Guru Training Management
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Greenlight Guru Introduces Training Management to Simplify Regulatory Compliance and Streamline the Employee Training Process
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Developing Pediatric Medical Devices: An Innovative Approach
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Greenlight Guru Announces The 2021 State of Medical Device Virtual Summit
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Everything You Need to Know about Human Factors Engineering for Your Medical Device
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Free Complaint Template for Medical Devices
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Free Template: Nonconformance Process for your Medical Device
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Greenlight Guru Introduces Quality Event Automation to Advance Efficiencies in the Management of Post-Market Quality Events
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3 Reasons Why Closed-Loop Traceability is a QMS Must
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519 Medical Device Manufacturers Reveal Biggest Barriers to Process Improvement
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Document Control for Medical Device Companies: The Ultimate Guide
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Unannounced Audits: A Survival Guide for Quality Managers
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How Do I Determine if my Product is a Medical Device?
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What is FDA's Approach to Regulating AI/ML in Software as a Medical Device?
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How to Escape the Lure of Legacy Quality Management Systems
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Medical Device Reporting (MDR): How to Take Advantage of Your Electronic Records
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How to Plan and Control the Design of your Medical Device while Meeting Regulatory Expectations
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How to Validate Cloud-based Software Tools
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Case Study: How Flexlogical Is Making Quality A Competitive Advantage By Adopting A Data-driven Approach With their Quality System
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EUA 101: What is Emergency Use Authorization and How can my Device get Authorized?
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How COVID-19 is Impacting the Medical Device Industry: Data, Benchmarks & Trends
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EU MDR Delay: How to Plan Beyond the Coronavirus Pandemic
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Greenlight Guru and EMERGO by UL Announce Strategic Alliance to Simplify and Automate Global Market Access for Medical Device Companies
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Documentation Priority for Early Stage Medtechs — Part 1: User Specification
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How to Approach Verification and Validation for Cloud Software
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How Software Architecture Enables Faster Release of New Clinical Tests to the Market
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What are the Changes to ISO 14971:2019 & TR 24971?
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COVID-19 Impact on Medical Device Industry: How to Navigate the Chaos and Support Public Health
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10 Ways A Modern, Cloud-Based QMS Helps Remote Teams Stay Ahead
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4 Emerging Trends in 2020 Backed by Medical Device Industry Experts
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Only 6% of Device Makers Are Ready for EU MDR — Are You? Here are 3 Ways to Transition Now
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Greenlight Guru Updates Risk Management Capabilities to Align with ISO 14971:2019, Further Enhances Change Management Capabilities
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7 FDA Pathways to Bring Your Medical Device to Market
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[VIDEO] 3 Easy Steps to Establishing a Quality & Regulatory Strategy for your Medical Device (Scope Phase)
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[VIDEO] How to Prepare your QMS for a Successful Medical Device Product Launch (Release Phase)
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[VIDEO] How to Calculate the Cost Of Quality: Building the Business Case for your Medical Device QMS
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[VIDEO] 7 Ways to Track QMS Effectiveness using Medical Device Post-market Quality Processes (Track Phase)
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[VIDEO] 4 Medical Device Manufacturing Best Practices for a Successful Design Transfer (Approve Phase)
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[VIDEO] Integrating Design Controls & Risk Management To Streamline Product Development (Make Phase)
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[VIDEO] How to build a QMS using the best people, processes & technology (S.M.A.R.T Methodology)
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Understanding Post-Market Surveillance Requirements for Medical Devices (US & EU Markets)
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4 Major Reasons to Use Document Version Control Software for your Medical Device
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The Art of Defining Design Inputs And Design Outputs
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The Greenlight Guru Advantage - More Than QMS Software [Customer Video Testimonial]
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3 Pros and Cons to 3D Printing for Medical Devices
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Greenlight Guru Announces Enhanced Change Management Capabilities
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LITG Case Study: Easily Documenting Design Controls to Accelerate Product Development
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FDA 21 CFR Part 820: 8 Most Common Mistakes to Avoid
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State of Medical Device Product Development and Quality Management Report 2020
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EU MDR Implementation Guide
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4 Biggest Challenges in Medical Device Manufacturing (and how to overcome them)
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Best Practices for Expediting Your Product Development
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5 Tips from MedTech Executives on the Value of Quality
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Why the FDA Pre-Submission is an Underutilized Tool
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How to Evaluate a Company’s Regulatory and Quality ‘Health’ Before Investing
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13 Tips For Audit Etiquette Every Medical Device Company Should Know
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Ultimate Guide to Agile Design and Development for Medical Devices
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6 Most Common Mistakes When Implementing ISO 13485
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How to Perform Effective Root Cause Analysis
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Should you Swipe Right or Left on your Notified Body?
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Why I Used To Hate Risk Management (And 3 Ways to Change Your Mind Too)
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FDA QSIT: Preparing Your Medical Device Company for an Inspection
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10 Essentials for Writing a Clear Product Requirements Document [Guide+Checklist]
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5 Most Common Mistakes Made When Implementing ISO 14971
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The Essential Guide to Preparing your QMS for EU MDR
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Qualifying Your Suppliers Using a Risk-based Approach
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How to Write Effective SOPs for Medical Devices
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ISO 13485 Medical Device Quality System Standard and Other Regulatory Conundrums
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Why Document Control Matters To Medical Device Companies
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Abbreviated 510(k): Substantial Equivalence Through Performance Criteria
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The Greenlight Guru True Quality Roadshow: Atlanta Recap
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Why Flexible Design Reviews Matter for Medical Device Product Development
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Greenlight Guru Announces Digital Design Reviews for Medical Device Product Development Teams
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Quality, Fast, Cheap...Pick Two
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What to Expect During an FDA QSIT Inspection
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5 Most Common Problems with your CAPA Process
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Introducing The Greenlight Guru True Quality Roadshow 2019
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Best Practices for Effective Medical Device Design Reviews
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Medical Device QMS Changes: How to Manage Changes Regarding EU MDR, IVDR & ISO 13485:2016
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Proactive Quality Systems: FDA Is Prioritizing Them...And You Should Too
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Why Contract Manufacturers Shouldn't Own Your Quality System
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FDA Case for Quality: 2018 Comprehensive Review
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Defining Your Medical Device Design Records
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6 Predictions for the Medical Device Industry in 2019 (and how you can prepare)
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ISO 13485 & MDSAP Deadlines are Fast Approaching (And You Need a Notified Body)
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FDA Computer System & Software Validation - What You’ve Known For 20+ Years Is Changing
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3 Real World Document Management Horror Stories
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Looking to join a fun, fast growing SaaS company? Greenlight Guru is hiring (Again)!
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Top 20 Medical Device Venture Capital Firms
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13 Steps to Creating a Risk-Based CAPA Process
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5 Myths Engineers Believe About Quality (and what is really true)
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Greenlight Guru Announces New Integration with Jira Software
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FDA Aligning to ISO 13485:2016 (and Why It Matters)
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What it Means to be Focused on Quality vs. Compliance
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What are the Regulatory Expectations for Software as a Medical Device (SaMD)?
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The Importance of Good Document Management (And How To Do It)
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Why the FDA Case for Quality Matters
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Greenlight Guru Announces Advanced Document Management
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Scaling Regulatory and Quality with Your Company
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FDA Case for Quality Program: What, Why and How?
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AI Explainability: What That Means and Why it Matters in Healthcare
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Challenging “Conventional Wisdom” in Medtech R and D
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Why There is a Need for Multi-Level Design Controls
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How a Partnership with Greenlight Guru Helped Rook Quality Systems Grow 15X in SIX Years
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What Medical Device Developers Should Know About Human Factors
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How Priority Designs Used Greenlight Guru to Gain ISO 13485:2016 Certification
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Creating an Effective Quality Culture that Benefits Your Patients
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Sneak Peek Into the ISO 14971 Revision Process (From a Member of the Standard's Working Group, JWG1)
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Greenlight Guru Announces Multi-Level Design Control Software
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Competitive Regulatory Strategy vs. Regular Regulatory Strategy
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Timeline to ISO 13485:2016 (And Why You Need to Act Today)
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7 Problems with a Paper-Based Design History File (And How to Avoid Them)
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Understanding the New Requirements for QMS Software Validation in ISO 13485:2016
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4 Tips for Handling Nonconformances
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Ultimate List of Medical Device Incubators and Accelerators (50+)
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5 Predictions for the Medical Device Industry in 2018 (And How You Can Prepare)
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What is Software as a Medical Device (SaMD)?
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Greenlight Guru Extends Platform with New Product, Grow, to Streamline PostMarket Quality Processes
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How to Prepare for the Medical Device Single Audit Program (MDSAP)
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How MEDDEV 2.7.1 Rev 4 Affects Medical Device Manufacturers
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Standard Conformity or Regulatory Compliance? Distinguishing the Two
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What Does a Risk-Based QMS Mean?
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What You Need to Know About the 510(k) Submission Process
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Why You Need To Stop Treating Risk Management & Design Controls as Checkbox Activities
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The Do’s and Don’ts of an FDA Inspection
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How to Translate Voice of Customer into User Needs
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How to Retroactively Create Design Controls and DHF (Even Though You Should Never Let This Happen)
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7 Common Mistakes That Can Delay Your FDA 510(k) Clearance
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Debunking 8 Commonly Held CAPA Myths
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How to Prepare Your Design History File (DHF) for an FDA Inspection
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13 Common Pitfalls to Avoid During Medical Device Product Development
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Design Validation vs. Clinical Evaluation: What’s the Difference?
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5 Tips for Conducting Medical Device Management Reviews
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Technical File vs. 510(k) vs. Design History File: What Medical Device Developers Should Know
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How To Prepare for an FDA Inspection (Plus 5 Tips)
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EU MDR and IVDR Are Live – Here Are Some Important Items You Should Know!
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Clinical Evaluation Reports — Things You Should Know About the MEDDEV 2.7/1 Revision 4
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Better Root Cause Analysis for Safer, More Effective Medical Devices
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CAPA: When to Take Corrective Action or Preventive Action?
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What is a “Quality Data Source” for your CAPA Process?
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Tips for Conducting Better Root Cause Analysis for Medical Device Companies
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This is a What … Unforeseen Pitfalls when Classifying a Medical Device
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EN ISO 14971:2012 Risk Assessment Explained in 5 Minutes… Using the Grossest Example Ever?
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Fundamentals of Supplier Management for Medical Device Companies
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4 Key Compliance Issues for Medical Device Companies
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What is CAPA in the Medical Device Industry?
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Key Challenges for Risk Management in Medical Device Development
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5 Things the Medical Device Industry Should Expect in 2017 (And How You Can Prepare)
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A Review of the Most Important Medical Device Industry Topics in 2016
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Tips for Success When It Comes to IEC 60601 with Leo Eisner
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The Business Case for Integrated Design Controls
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Medical Device Risk – ISO 14971 Gets It Right
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An Introduction to FDA 21 CFR Part 11
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FDA 21 CFR Part 820 vs. ISO 13485:2016 vs. ISO 13485:2003
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What's with the Rush to First-In-Human Studies?
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Why Poor Design Controls Mean More Medical Device Complaints
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Greenlight Guru Invited to Host Two Workshop Sessions at RAPS Convergence San Jose 2016
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How To Avoid Being Part of the 69% of 510(k) Submissions That Get Rejected the First Time
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Why Use ISO 14971 vs. FMEA (Template Included)
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What It Means to Join the Greenlight Guru Family
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Recovery Force Accelerates Their Product Development Efforts Using Greenlight Guru [Case Study]
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8 Reasons Why Your Design Controls And Risk Management Processes Fail
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5 Medical Device Project Management Tips That Will Help You Complete Your Project On Time
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4 Medical Device Quality System Musts for Startups
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4 Lessons I Learned Going Through an FDA / ISO Audit for the First Time as an Engineer
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Top 9 Reasons Device Makers Received FDA Form 483 and Warning Letters in 2015
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Understanding Risk in Medical Device New Product Development (NPD)
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Is Your Company Disconnected from the Medical Device Regulations It Must Abide By?
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Acronyms You Need To Know When Evaluating Medical Device Software Solutions
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Top 3 Document Management Tips for Medical Device Companies
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How To Navigate the Difficult Road of Medical Device Product Development While Avoiding the Common Pitfalls
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4 Reasons Why Your Risk Management Approach is Wrong
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Best Document Management Practices for Medical Device Startups: Don’t Cheap Out
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Why Getting FDA 510(k) Clearance Alone is Not Enough (And 6 Things You Can Do About It)
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Sandstone Diagnostics Case Study: Moving from a Paper-based QMS to Greenlight Guru
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5 Reasons Why You Need To Implement a QMS or Bust
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Greenlight Guru Wins 2015 Indiana Innovation Award
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The Many Connotations Of Risk In Medtech Development — And The Consequences Of Getting Them Wrong
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Does Your Medical Device Startup Suffer from CEO Disconnect Syndrome?
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How To Flush $400,000 Down the Drain Fighting the FDA
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Design Reviews – Are More or Less Better?
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A Brief Introduction to Medical Device Risk Management (Plus 5 Tips)
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How To Avoid a Medtech Documents & Records Scavenger Hunt
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Join Us in Memphis for #ZeroToGreenlight - Why Worrying About FDA Regulations Matters
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5 Tips to Help Your FDA 510(k) Submission (checklist included)
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2 Things You Need To Do ASAP When Starting A Medical Device Project
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How To Reduce & Prevent Medical Device Complaints
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Medical Device Product Development Case Study
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Changing Medical Device Design Control
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You do know Design Controls are required for medical devices, right?
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An FDA Inspection Will Happen
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Design Controls are the #1 Most Cited Issue with FDA
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Real-World Data and Real-World Evidence: When and How to Use Them
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Clinical Trials in 2025: The Outlook for Medical Device Companies
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Introducing Document Comparison: Boost Audit Readiness, Accelerate Training, and Streamline Approvals
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