EASY TO USE, FAST TO IMPLEMENT MEDICAL DEVICE QUALITY MANAGEMENT SOFTWARE THAT CONNECTS DISPARATE PROCESSES, SOURCES, PEOPLE, AND DATA FOR THE FIRST TIME EVER. INCREASED VISIBILITY SMOOTHS YOUR PATH TO COMPLIANCE AND LETS YOU FOCUS ON TRUE QUALITY.

Achieve End-to-End Traceability
Automate Quality, Risk, & Design Processes
Follow FDA & ISO Best Practices
Streamline Team Communication

About Greenlight Guru

	Started in 2013 by medical device industry veterans
	Only True Cloud QMS with fully connected Design Controls & Risk
	Headquartered in Indianapolis, IN
	Hundreds of customers on six continents

The only Medical Device QMS Solution Provider To Be Named A Category Leader By G2 Crowd TEN Quarters In A RoW

With Greenlight Guru, you can launch new devices faster, streamline quality, and simplify compliance with a single source of truth that unites the team.

Greenlight Guru simplifies quality management and compliance. We keep our solution packages simple, too. Our software packages are built to make it easy for you to adopt our platform. The difference amongst the packages is based on the needs of your team and business at different stages of your companies growth.

$125,000 saved on average cost estimated per project
Improved culture during project cycle
2.5 months faster to market

402 hours saved on low value-added activities
Single source of truth for all quality processes
Better audit readiness

Greenlight Guru has been instrumental for us while we efficiently navigate the quality management system process and with developing our FDA Submission.

Ryan Nolan

Co-Founder & VP of Clinical Operations PhotoniCare

We wanted a QMS that was robust enough to grow with us, but simple enough to get us started.

kevin mcleod

ceo at c2dx, inc

BEST QMS SOFTWARE: ULTIMATE GUIDE TO COMPARING QUALITY MANAGEMENT SYSTEM SOLUTIONS		15 QUESTIONS TO ASK QMS SOFTWARE VENDORS IN THE MEDICAL DEVICE INDUSTRY		5 DO'S AND DON'TS WHEN CHOOSING A QMS SOLUTION FOR YOUR MEDICAL DEVICE COMPANY
The best QMS software comparison guide for medical device companies that will help you choose a quality management system solution that strategically benefits your product and company.		Know what questions to ask software vendors that give your medical device company the necessary information to consider when selecting a QMS software solution.		A guide to the top 5 recommended best practices that medical device companies should consider when choosing a quality management system (QMS) solution.

A COMPLETE GUIDE TO BRINGING A MEDICAL DEVICE TO MARKET		ISO 13485 - ULTIMATE GUIDE TO THE QUALITY MANAGEMENT SYSTEM (QMS) FOR MEDICAL DEVICES		DEFINITIVE GUIDE TO ISO 14971:2019 RISK MANAGEMENT FOR MEDICAL DEVICES
A complete guide for medical device manufacturers looking for guidance on how to plan for a successful product launch and maintain regulatory compliance across global markets.		Greenlight Guru eQMS platform automates regulatory compliance with ISO 13485:2016, FDA, ISO 14971, so companies can focus on true quality of devices.		Learn the most up to date recommendations and best practices from the ISO 14971:2019 standard and how you can start to use risk management as a tool - not a checkbox activity.

Get your free
quality management software demo

Complete Medical Device Quality Management Software Platform

We Help Medical Device Companies Get to Market Faster & Achieve True Quality

A Connected Quality Ecosystem

That Unites Your Whole Team

THE ONLY QUALITY MANAGEMENT SOFTWARE DESIGNED SPECIFICALLY FOR THE MEDICAL DEVICE INDUSTRY

About Greenlight Guru

The only Medical Device QMS Solution Provider To Be Named A Category Leader By G2 Crowd TEN Quarters In A RoW

DERIVE VALUE IN YOUR FIRST 30 DAYS WITH GREENLIGHT GURU

With Greenlight Guru, you can launch new devices faster, streamline quality, and simplify compliance with a single source of truth that unites the team.

WHAT YOUR TEAM CAN EXPECT WITH GREENLIGHT GURU

INNOVATIVE MEDICAL DEVICE COMPANIES LIKE YOURS FIND SUCCESS WITH GREENLIGHT GURU

Greenlight Guru has been instrumental for us while we efficiently navigate the quality management system process and with developing our FDA Submission.

Ryan Nolan

Co-Founder & VP of Clinical Operations PhotoniCare

We wanted a QMS that was robust enough to grow with us, but simple enough to get us started.

kevin mcleod

ceo at c2dx, inc

RESOURCES TO HELP YOUR DEVICE COMPANY MOVE BEYOND BASELINE COMPLIANCE TO TRUE QUALITY

BEST QMS SOFTWARE: ULTIMATE GUIDE TO COMPARING QUALITY MANAGEMENT SYSTEM SOLUTIONS

15 QUESTIONS TO ASK QMS SOFTWARE VENDORS IN THE MEDICAL DEVICE INDUSTRY

5 DO'S AND DON'TS WHEN CHOOSING A QMS SOLUTION FOR YOUR MEDICAL DEVICE COMPANY

A COMPLETE GUIDE TO BRINGING A MEDICAL DEVICE TO MARKET

ISO 13485 - ULTIMATE GUIDE TO THE QUALITY MANAGEMENT SYSTEM (QMS) FOR MEDICAL DEVICES

DEFINITIVE GUIDE TO ISO 14971:2019 RISK MANAGEMENT FOR MEDICAL DEVICES

Get your free
quality management software demo

YES, I WANT A DEMO!

Complete Medical Device Quality Management Software Platform

We Help Medical Device Companies Get to Market Faster & Achieve True Quality

Schedule your free demo

A Connected Quality Ecosystem

That Unites Your Whole Team

THE ONLY QUALITY MANAGEMENT SOFTWARE DESIGNED SPECIFICALLY FOR THE MEDICAL DEVICE INDUSTRY

About Greenlight Guru

The only Medical Device QMS Solution Provider To Be Named A Category Leader By G2 Crowd TEN Quarters In A RoW

DERIVE VALUE IN YOUR FIRST 30 DAYS WITH GREENLIGHT GURU

With Greenlight Guru, you can launch new devices faster, streamline quality, and simplify compliance with a single source of truth that unites the team.

WHAT YOUR TEAM CAN EXPECT WITH GREENLIGHT GURU

INNOVATIVE MEDICAL DEVICE COMPANIES LIKE YOURS FIND SUCCESS WITH GREENLIGHT GURU

Greenlight Guru has been instrumental for us while we efficiently navigate the quality management system process and with developing our FDA Submission.

Ryan Nolan

Co-Founder & VP of Clinical Operations PhotoniCare

We wanted a QMS that was robust enough to grow with us, but simple enough to get us started.

kevin mcleod

ceo at c2dx, inc

RESOURCES TO HELP YOUR DEVICE COMPANY MOVE BEYOND BASELINE COMPLIANCE TO TRUE QUALITY

BEST QMS SOFTWARE: ULTIMATE GUIDE TO COMPARING QUALITY MANAGEMENT SYSTEM SOLUTIONS

15 QUESTIONS TO ASK QMS SOFTWARE VENDORS IN THE MEDICAL DEVICE INDUSTRY

5 DO'S AND DON'TS WHEN CHOOSING A QMS SOLUTION FOR YOUR MEDICAL DEVICE COMPANY

A COMPLETE GUIDE TO BRINGING A MEDICAL DEVICE TO MARKET

ISO 13485 - ULTIMATE GUIDE TO THE QUALITY MANAGEMENT SYSTEM (QMS) FOR MEDICAL DEVICES

DEFINITIVE GUIDE TO ISO 14971:2019 RISK MANAGEMENT FOR MEDICAL DEVICES

Get your freequality management software demo

YES, I WANT A DEMO!

Get your free
quality management software demo