<img src="https://ws.zoominfo.com/pixel/OJkQgdjSvoid2NFoB5Qs" width="1" height="1" style="display: none;">
FREE DOWNLOADS

TIPS, CHECKLISTS, AND TEMPLATES FROM SEASONED MEDICAL DEVICE PROFESSIONALS AVAILABLE AT YOUR FINGERTIPS

More than 68,000 rely on us for the latest in quality

3 Tips for Receiving EUA from FDA

Download the Resource

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

Download the Resource

IVDR Gap Assessment Tool

Download the Resource

MDD vs. MDR Gap Assessment Tool

Download the Resource

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

Download the Resource

Content Toolkit for Medical Device Executive Leaders

Download the Resource

Content Toolkit for Medical Device QA/RA Professionals

Download the Resource

Content Toolkit for Medical Device Product Developers

Download the Resource

Quality Culture Flowchart

Download the Resource

EU MDR: SaMD Guidance Document + Audit Gap Assessment Tool

Download the Resource

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

Download the Resource

Product Requirements Guide + Checklist with Writing Tips

Download the Resource

MDSAP vs. ISO 13485:2016 Gap Assessment Tool

Download the Resource

EU MDR Gap Analysis Tool

Download the Resource

Suggested Quality Domain Metrics

Download the Resource

Compliance or Quality Focused Comparison Chart

Download the Resource

What Influences SaMD Classification?

Download the Resource

Benefits of a Formal Document Management Solution

Download the Resource

5 FDA 510(k) Submission Mistakes to Avoid

Download the Resource

What Medical Device Investors Want to See Checklist

Download the Resource

FDA Program Comparison Table

Download the Resource

4 Cornerstones of an Effective eQMS

Download the Resource

6 Ways AI is Transforming Healthcare

Download the Resource

Top 100 Medical Device Companies in the World Chart

Download the Resource

5 Practical R&D Tips for Medical Device Developers

Download the Resource

Key Questions for Defining User Needs

Download the Resource

7 Tips for Incorporating Human Factors into Device Design

Download the Resource

Tips to Building Consistent QMS Procedures

Download the Resource

5 Tips for a Competitive Regulatory Strategy

Download the Resource

5 Tips for Better DHF Management Cheat Sheet

Download the Resource

Most Common Sources of Post-market Surveillance Data

Download the Resource

15 Steps to Create a Risk-based CAPA Process Infographic

Download the Resource

Ultimate List of Medical Device Incubators & Accelerators

Download the Resource

4 Steps to Gathering Accurate Complaint Data

Download the Resource

Overview of a Customer Complaint-handling Procedure

Download the Resource

Guide to When to Use Different Tools for CAPA Analysis

Download the Resource

FDA 483 & Warning Letter Checklist

Download the Resource

510(k) Submission Checklist

Download the Resource

Cheat Sheet on Preparing Your Team for an FDA Inspection

Download the Resource

7 Signs You're Ready for an eQMS

Download the Resource

5 Ways to Prepare Your Team for an FDA Inspection

Download the Resource

6 Survey Tools for Gathering User Needs

Download the Resource

Using Your 510(k) Submission for Design Controls and DHF Table

Download the Resource

5 Tips for Using a Predicate Device

Download the Resource

4 Signs You Need to Issue a CAPA

Download the Resource

Key Elements of Your Design History File Checklist

Download the Resource

10 Resources to Get Medical Device Companies on Track

Download the Resource

5 Key Steps for Getting Your Medical Device CE Mark

Download the Resource

Sample Management Review Template

Download the Resource

Tips to Help Define User Needs

Download the Resource

4 Helpful Tips for Better Management of Your Design History File

Download the Resource

9 Tips for Password Compliance with 21 CFR Part 11

Download the Resource

4 Reasons the Root Cause Isn't "User Error" Cheatsheet

Download the Resource

What FDA Expects to See as Part of Your CAPA Process Cheatsheet

Download the Resource

5 Step Checklist to Determine If a CAPA Is Required

Download the Resource

Checklist for Selecting Suppliers to Your Medical Device Company

Download the Resource

4 Methods for Root Cause Analysis Cheat Sheet

Download the Resource

7 Rules for Effective Medical Device Design Controls Cheat Sheet

Download the Resource

5 "Whys" for Root Cause Analysis Technique Cheat Sheet

Download the Resource

5 Tips for a Successful 510(k) Submission

Download the Resource

8 Quick Facts about CAPA Cheat Sheet

Download the Resource

ISO 13485:2016: Changes You Should Know About

Download the Resource

ISO 13485:2016 vs FDA 21 CFR Part 820 Full Comparison Table

Download the Resource

Failure Mode Effects Analysis (FMEA) Template

Download the Resource

Medical Device Product Development Checklist

Download the Resource

FDA QSR & ISO 13485: 2016 Internal QMS Audit Checklist

Download the Resource

FDA 483/Warning Letter Response Template

Download the Resource

Risk Management Plan Template

Download the Resource

5 Tips to Help your FDA 510(k) Submission

Download the Resource
© 2020 Greenlight Guru
Third party trademarks, logos and trade names appearing on the site are the property of their respective owners. Legal