Free Medical Device Templates & Checklists | Greenlight Guru
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Free Templates
- QMSR Readiness Playbook
- QMSR Gap Assessment Tool | Free Download
- Complaint Log + Form Template Bundle
- Verification Protocol Template
- Content Toolkit for Medical Device Product Developers
- FDA Pre-Submission Meeting Checklist for Medical Device Companies
- GSPR Template
- Medical Devices Essential Principles Checklist
- MDSAP QMS Audit Checklist
- Clinical Investigation Plan (CIP) Synopsis Template
- Resource Bundle for Risk Managers
- FDA QSR, QMSR & ISO 13485:2016 Internal Audit Checklist
- Premarket Approval Inspection Checklist
- MDSAP vs. ISO 13485:2016 Gap Assessment Tool
- FDA QMSR & ISO 13485:2016 QMS Internal Audit Checklist
- Cybersecurity Gap Assessment Checklist
- Align Your Clinical Claims Webinar Q&A
- ChatGPT Sample Prompts for Risk Evaluation of a Medical Device
- Training Matrix Template
- How to Clear a Software Medical Device
- Validation Toolkit
- Class 1 Medical Device Content Bundle
- Class 2 Medical Device Content Bundle
- Class 3 Medical Device Content Bundle
- Clinical Evaluation Toolkit
- MDR & IVDR Gap Analysis Toolkit
- Budgeting for MedTech Clinical Activities Checklist
- Checklist for Protecting your IP throughout the MedTech Lifecycle
- What to Include in Your Quality Assurance Agreement with a Distributor
- QMS Implementation Checklist Template
- Quality Management System (QMS) Software Vendor Checklist
- ISO 14971:2019 Gap Analysis Tool
- 15-in-1 MedTech Template Bundle
- General Safety and Performance Requirements (GSPR) Gap Assessment
- Top 30 MDCG Guidance Documents for Medical Device Companies
- Top 40 IMDRF Technical Documents for Medical Devices
- MDD vs. MDR Gap Assessment Tool
- Checklist for Clinical Data Collection and Efficient Study Setup
- Checklist to Evaluate Your Quality Control Process
- 5 Tips for IEC 60601 Submissions
- 21 CFR Part 11 compliance checklist for clinical records and e-signatures
- How to Plan a Clinical Data Management Setup for EDC Systems
- Medical Device Reporting (MDR) Decision Tree
- Complaint Form Template
- EU MDR Gap Analysis Tool
- CAPA Report Template
- 5 Tips for a Successful 510(k) Submission
- 10 Resources to Get Medical Device Companies on Track
- 6 Tips for a Seamless Document Migration to Greenlight Guru
- Design Transfer to Manufacturing
- Clinical Evaluation Procedure Template
- Quality Event Template Package for CAPAs, Complaints & Nonconformities
- Checklist for Structuring Your Technical Documentation
- Checklist: Premarket Submission Documentation for Devices Containing Software
- FDA Labeling Requirements Checklist
- Abbreviated 510(k) Submission Checklist
- Periodic Safety Update Report Template
- How To Prepare An FDA Pre-Submission
- 10 Ways A Modern, Cloud-Based Medical Device QMS Helps Remote Teams Stay Ahead
- 3 Tips for Receiving EUA from FDA
- 7 Steps for Writing a Nonconformance Report
- Human Factors & Usability Engineering Report
- Biocompatibility Testing Selection Criteria
- Top 100 Medical Device Startups with Most Money Raised in 2020 Chart
- Value of True Quality Infographic
- Checklist: 7 Steps to Comply with FDA 21 CFR Part 11
- Free Replay Package: 2021 Medical Device Virtual Summit
- Nonconformance Report Template
- Change Order Template
- Change Impact Analysis Template
- Legacy vs Best-in-Class QMS Tools Comparison Chart
- Total Quality Management 4-in-1 Tool
- 510(k) Program Comparison Chart
- Medical Device Project Plan
- 5 Steps for Creating a Traceability Matrix
- Clinical Investigation Report Checklist
- Approved Supplier List Form Template
- 21 CFR Part 820 Resource Pocket Guide for Avoiding Most Common Mistakes
- Quality Culture Flowchart
- 5 Myths about PMA's (and what's actually true)
- 4 Signs You Need to Issue a CAPA
- 5 Tips for Using a Predicate Device
- Using Your 510(k) Submission for Design Controls and DHF Table
- 5 Ways to Prepare Your Team for an FDA Inspection
- 7 Signs You're Ready for an eQMS
- Cheat Sheet on Preparing Your Team for an FDA Inspection
- 510(k) Submission Checklist
- FDA 483 & Warning Letter Checklist
- Guide to When to Use Different Tools for CAPA Analysis
- Overview of a Customer Complaint-handling Procedure
- 4 Steps to Gathering Accurate Complaint Data
- Ultimate List of Medical Device Incubators & Accelerators
- 15 Steps to Create a Risk-based CAPA Process Infographic
- Most Common Sources of Post-market Surveillance Data
- 5 Tips for Better DHF Management Cheat Sheet
- 5 Tips for a Competitive Regulatory Strategy
- Tips to Building Consistent QMS Procedures
- 7 Tips for Incorporating Human Factors into Device Design
- 10 Key Questions for Defining User Needs
- 5 Practical R&D Tips for Medical Device Developers
- Top 100 Medical Device Companies in the World Chart
- 6 Ways AI is Transforming Healthcare
- 4 Cornerstones of an Effective eQMS
- FDA Program Comparison Table
- What Medical Device Investors Want to See Checklist
- 5 FDA 510(k) Submission Mistakes to Avoid
- Benefits of a Formal Document Management Solution
- What Influences SaMD Classification?
- Compliance or Quality Focused Comparison Chart
- Suggested Quality Domain Metrics
- FDA QSR & ISO 13485: 2016 Internal QMS Audit Checklist
- Medical Device Product Development Checklist
- Failure Mode Effects Analysis (FMEA) Template
- ISO 13485:2016 vs FDA 21 CFR Part 820 Full Comparison Table
- ISO 13485:2016: Changes You Should Know About
- 8 Quick Facts about CAPA Cheat Sheet
- 5 "Whys" for Root Cause Analysis Technique Cheat Sheet
- 7 Rules for Effective Medical Device Design Controls Cheat Sheet
- 4 Methods for Root Cause Analysis Cheat Sheet
- 5 Step Checklist to Determine If a CAPA Is Required
- What FDA Expects to See as Part of Your CAPA Process Cheatsheet
- 4 Reasons the Root Cause Isn't "User Error" Cheatsheet
- 9 Tips for Password Compliance with 21 CFR Part 11
- 4 Helpful Tips for Better Management of Your Design History File
- Tips to Help Define User Needs
- Sample Management Review Template
- 5 Key Steps for Getting Your Medical Device CE Mark
- Key Elements of Your Design History File Checklist
- Checklist For Selecting Suppliers + Contract Manufacturers
- FDA 483/Warning Letter Response Template
- Risk Management Plan Template
- Content Toolkit for Medical Device Startups
- IVDR Gap Assessment Tool
- Content Toolkit for Medical Device Executive Leaders
- Content Toolkit for Medical Device QA/RA Professionals
- EU MDR Economic Operators Guidance Document
- EU MDR: SaMD Guidance Document + Audit Gap Assessment Tool