<img src="https://ws.zoominfo.com/pixel/OJkQgdjSvoid2NFoB5Qs" width="1" height="1" style="display: none;">
Careers Support Contact Sales
Products

Greenlight Guru QMS

More than a Quality Management System: Tools for the entire MedTech Lifecycle.

Learn More

Featured Capabilities:

Document Management Product Development Design Control Risk Solutions Training Management CAPA Management

Experience the #1 QMS software for medical device companies first-hand. Click through an interactive demo.

View Product Tour

SMART-TRIAL by
Greenlight Guru

Data gathering and management designed for MedTech clinical trials and operations.

Learn More

Featured Capabilities:

Electronic Case Report Forms (eCRF) Electronic Patient Reported Outcomes (ePRO) Ad-Hoc Data Collection (Cases) Post-Market Surveys

Get a personalized demo of SMART-TRIAL by Greenlight Guru today.

See the demo

Greenlight Guru Academy

Learn valuable, career-boosting skills for the Medical Device industry. Get access to hundreds of free resources as well as subscription-based courses and certifications.

Learn More
Solutions
Why Us
Customers
Partners
Company
Resources
image-mckp (1)-1

Discover the new trends, outlooks, challenges, and opportunities in the MedTech industry in 2023.

Grab a copy
See the Demo
See the Demo
See the Demo

Free Downloads:
Checklists & Templates

Tips, checklists, and templates from seasoned medical device professionals available at your fingertips.

No results

Checklists and Templates

Checklist for Protecting your IP throughout the MedTech Lifecycle

Learn More
Checklists and Templates

What to Include in Your Quality Assurance Agreement with a Distributor

Learn More
Checklists and Templates

QMS Implementation Checklist Template

Learn More
Checklists and Templates

Quality Management System (QMS) Software Vendor Checklist

Learn More
Checklists and Templates

ISO 14971:2019 Gap Analysis Tool

Learn More
Checklists and Templates

15-in-1 MedTech Template Bundle

Learn More
Checklists and Templates

General Safety and Performance Requirements (GSPR) Gap Assessment

Learn More
Checklists and Templates

5 Tips for IEC 60601 Submissions

Learn More
Checklists and Templates

EU MDR Economic Operators Guidance Document

Learn More
Checklists and Templates

5 "Whys" for Root Cause Analysis Technique Cheat Sheet

Learn More
Checklists and Templates

CAPA Report Template

Learn More
Checklists and Templates

Quality Event Template Package for CAPAs, Complaints & Nonconformities

Learn More
Checklists and Templates

Clinical Evaluation Procedure Template

Learn More
Checklists and Templates

Checklist to Evaluate Your Quality Control Process

Learn More
Checklists and Templates

Design Transfer to Manufacturing

Learn More
Checklists and Templates

Medical Device Reporting (MDR) Decision Tree

Learn More
Checklists and Templates

How To Prepare An FDA Pre-Submission

Learn More
Checklists and Templates

Periodic Safety Update Report Template

Learn More
Checklists and Templates

Abbreviated 510(k) Submission Checklist

Learn More
Checklists and Templates

Checklist For Selecting Suppliers + Contract Manufacturers

Learn More
Checklists and Templates

FDA Labeling Requirements Checklist

Learn More
Checklists and Templates

Checklist: Premarket Submission Documentation for Devices Containing Software

Learn More
Checklists and Templates

Checklist for Structuring Your Technical Documentation

Learn More
Checklists and Templates

Approved Supplier List Form Template

Learn More
Checklists and Templates

Clinical Investigation Report Checklist

Learn More
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 ...

Learn More
Checklists and Templates

Content Toolkit for Medical Device Startups

Learn More
Checklists and Templates

MDR & IVDR Gap Analysis Toolkit

Learn More
Checklists and Templates

5 Steps for Creating a Traceability Matrix

Learn More
Checklists and Templates

Medical Device Project Plan

Learn More
Checklists and Templates

510(k) Program Comparison Chart

Learn More
Checklists and Templates

Total Quality Management 4-in-1 Tool

Learn More
Checklists and Templates

Legacy vs Best-in-Class QMS Tools Comparison Chart

Learn More
Checklists and Templates

Change Impact Analysis Template

Learn More
Checklists and Templates

Change Order Template

Learn More
Checklists and Templates

Nonconformance Report Template

Learn More
Checklists and Templates

Free Replay Package: 2021 Medical Device Virtual Summit

Learn More
Checklists and Templates

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

Learn More
Checklists and Templates

Value of True Quality Infographic

Learn More
Checklists and Templates

Training Matrix Template

Learn More
Checklists and Templates

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

Learn More
Checklists and Templates

Biocompatibility Testing Selection Criteria

Learn More
Checklists and Templates

Human Factors & Usability Engineering Report

Learn More
Checklists and Templates

Complaint Template

Learn More
Checklists and Templates

CAPA Template

Learn More
Checklists and Templates

7 Steps for Writing a Nonconformance Report

Learn More
Checklists and Templates

3 Tips for Receiving EUA from FDA

Learn More
Checklists and Templates

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

Learn More
Checklists and Templates

IVDR Gap Assessment Tool

Learn More
Checklists and Templates

MDD vs. MDR Gap Assessment Tool

Learn More
Checklists and Templates

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

Learn More
Checklists and Templates

Content Toolkit for Medical Device Executive Leaders

Learn More
Checklists and Templates

Content Toolkit for Medical Device QA/RA Professionals

Learn More
Checklists and Templates

Content Toolkit for Medical Device Product Developers

Learn More
Checklists and Templates

Quality Culture Flowchart

Learn More
Checklists and Templates

EU MDR: SaMD Guidance Document + Audit Gap Assessment Tool

Learn More
Checklists and Templates

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

Learn More
Checklists and Templates

MDSAP vs. ISO 13485:2016 Gap Assessment Tool

Learn More
Checklists and Templates

EU MDR Gap Analysis Tool

Learn More
Checklists and Templates

Suggested Quality Domain Metrics

Learn More
Checklists and Templates

Compliance or Quality Focused Comparison Chart

Learn More
Checklists and Templates

What Influences SaMD Classification?

Learn More
Checklists and Templates

Benefits of a Formal Document Management Solution

Learn More
Checklists and Templates

5 FDA 510(k) Submission Mistakes to Avoid

Learn More
Checklists and Templates

What Medical Device Investors Want to See Checklist

Learn More
Checklists and Templates

FDA Program Comparison Table

Learn More
Checklists and Templates

4 Cornerstones of an Effective eQMS

Learn More
Checklists and Templates

6 Ways AI is Transforming Healthcare

Learn More
Checklists and Templates

Top 100 Medical Device Companies in the World Chart

Learn More
Checklists and Templates

5 Practical R&D Tips for Medical Device Developers

Learn More
Checklists and Templates

10 Key Questions for Defining User Needs

Learn More
Checklists and Templates

7 Tips for Incorporating Human Factors into Device Design

Learn More
Checklists and Templates

Tips to Building Consistent QMS Procedures

Learn More
Checklists and Templates

5 Tips for a Competitive Regulatory Strategy

Learn More
Checklists and Templates

5 Tips for Better DHF Management Cheat Sheet

Learn More
Checklists and Templates

Most Common Sources of Post-market Surveillance Data

Learn More
Checklists and Templates

15 Steps to Create a Risk-based CAPA Process Infographic

Learn More
Checklists and Templates

Ultimate List of Medical Device Incubators & Accelerators

Learn More
Checklists and Templates

4 Steps to Gathering Accurate Complaint Data

Learn More
Checklists and Templates

Overview of a Customer Complaint-handling Procedure

Learn More
Checklists and Templates

Guide to When to Use Different Tools for CAPA Analysis

Learn More
Checklists and Templates

FDA 483 & Warning Letter Checklist

Learn More
Checklists and Templates

510(k) Submission Checklist

Learn More
Checklists and Templates

Cheat Sheet on Preparing Your Team for an FDA Inspection

Learn More
Checklists and Templates

7 Signs You're Ready for an eQMS

Learn More
Checklists and Templates

5 Ways to Prepare Your Team for an FDA Inspection

Learn More
Checklists and Templates

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

Learn More
Checklists and Templates

5 Tips for Using a Predicate Device

Learn More
Checklists and Templates

4 Signs You Need to Issue a CAPA

Learn More
Checklists and Templates

Key Elements of Your Design History File Checklist

Learn More
Checklists and Templates

10 Resources to Get Medical Device Companies on Track

Learn More
Checklists and Templates

5 Key Steps for Getting Your Medical Device CE Mark

Learn More
Checklists and Templates

Sample Management Review Template

Learn More
Checklists and Templates

Tips to Help Define User Needs

Learn More
Checklists and Templates

4 Helpful Tips for Better Management of Your Design History File

Learn More
Checklists and Templates

9 Tips for Password Compliance with 21 CFR Part 11

Learn More
Checklists and Templates

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

Learn More
Checklists and Templates

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

Learn More
Checklists and Templates

5 Step Checklist to Determine If a CAPA Is Required

Learn More
Checklists and Templates

Checklist for Selecting Suppliers to Your Medical Device Company

Learn More
Checklists and Templates

4 Methods for Root Cause Analysis Cheat Sheet

Learn More
Checklists and Templates

7 Rules for Effective Medical Device Design Controls Cheat Sheet

Learn More
Checklists and Templates

5 "Whys" for Root Cause Analysis Technique Cheat Sheet

Learn More
Checklists and Templates

5 Tips for a Successful 510(k) Submission

Learn More
Checklists and Templates

8 Quick Facts about CAPA Cheat Sheet

Learn More
Checklists and Templates

ISO 13485:2016: Changes You Should Know About

Learn More
Checklists and Templates

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

Learn More
Checklists and Templates

Failure Mode Effects Analysis (FMEA) Template

Learn More
Checklists and Templates

Medical Device Product Development Checklist

Learn More
Checklists and Templates

FDA QSR & ISO 13485: 2016 Internal QMS Audit Checklist

Learn More
Checklists and Templates

FDA 483/Warning Letter Response Template

Learn More
Checklists and Templates

Risk Management Plan Template

Learn More
Checklists and Templates

5 Tips to Help your FDA 510(k) Submission

Learn More