Free Medical Device Templates & Checklists

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Ultimate Guide to Comparing Quality Management System Solutions

Checklists & Templates

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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