Free Medical Device Templates & Checklists

Checklists and Templates

6 Tips for a Seamless Document Migration to Greenlight Guru

"Greenlight Guru provides an Electronic Quality Management System (eQMS) for medical device companies to ensure quality standards are met without requiring that the end ...

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Quality Event Template Package for CAPAs, Complaints & Nonconformities

Clinical Evaluation Procedure Template

Checklist to Evaluate Your Quality Control Process

Design Transfer to Manufacturing

Medical Device Reporting (MDR) Decision Tree

How To Prepare An FDA Pre-Submission

Periodic Safety Update Report Template

Abbreviated 510(k) Submission Checklist

Checklist For Selecting Suppliers + Contract Manufacturers

FDA Labeling Requirements Checklist

Checklist: Premarket Submission Documentation for Devices Containing Software

Checklist for Structuring Your Technical Documentation

Approved Supplier List Form Template

Clinical Investigation Report Checklist

6 Tips for a Seamless Document Migration to Greenlight Guru

Content Toolkit for Medical Device Startups

MDR & IVDR Gap Analysis Toolkit

5 Steps for Creating a Traceability Matrix

Medical Device Project Plan

510(k) Program Comparison Chart

Total Quality Management 4-in-1 Tool

Legacy vs Best-in-Class QMS Tools Comparison Chart

Change Impact Analysis Template

Change Order Template

Nonconformance Report Template

Free Replay Package: 2021 Medical Device Virtual Summit

Checklist: 7 Steps to Comply with FDA 21 CFR Part 11

Value of True Quality Infographic

Training Matrix Template

Top 100 Medical Device Startups with Most Money Raised in 2020 Chart

Biocompatibility Testing Selection Criteria

Human Factors & Usability Engineering Report

Complaint Template

Nonconformance Template

CAPA Template

7 Steps for Writing a Nonconformance Report

3 Tips for Receiving EUA from FDA

10 Ways A Modern, Cloud-Based MDQMS Helps Remote Teams Stay Ahead

IVDR Gap Assessment Tool

MDD vs. MDR Gap Assessment Tool

5 Myths about PMA's (and what's actually true)

Content Toolkit for Medical Device Executive Leaders

Content Toolkit for Medical Device QA/RA Professionals

Content Toolkit for Medical Device Product Developers

Quality Culture Flowchart

EU MDR: SaMD Guidance Document + Audit Gap Assessment Tool

21 CFR Part 820 Resource Pocket Guide for Avoiding Most Common Mistakes

MDSAP vs. ISO 13485:2016 Gap Assessment Tool

EU MDR Gap Analysis Tool

Suggested Quality Domain Metrics

Compliance or Quality Focused Comparison Chart

What Influences SaMD Classification?

Benefits of a Formal Document Management Solution

5 FDA 510(k) Submission Mistakes to Avoid

What Medical Device Investors Want to See Checklist

FDA Program Comparison Table

4 Cornerstones of an Effective eQMS

6 Ways AI is Transforming Healthcare

Top 100 Medical Device Companies in the World Chart

5 Practical R&D Tips for Medical Device Developers

Key Questions for Defining User Needs

7 Tips for Incorporating Human Factors into Device Design

Tips to Building Consistent QMS Procedures

5 Tips for a Competitive Regulatory Strategy

5 Tips for Better DHF Management Cheat Sheet

Most Common Sources of Post-market Surveillance Data

15 Steps to Create a Risk-based CAPA Process Infographic

Ultimate List of Medical Device Incubators & Accelerators

4 Steps to Gathering Accurate Complaint Data

Overview of a Customer Complaint-handling Procedure

Guide to When to Use Different Tools for CAPA Analysis

FDA 483 & Warning Letter Checklist

510(k) Submission Checklist

Cheat Sheet on Preparing Your Team for an FDA Inspection

7 Signs You're Ready for an eQMS

5 Ways to Prepare Your Team for an FDA Inspection

6 Survey Tools for Gathering User Needs

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Checklists & Templates