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

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

 

Discover the power of end-to-end traceability ↓↓

 

 

 

 

 

About Greenlight Guru

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

 

 

 

g2-crowd-badges-1
 
 
The only Medical Device QMS Solution Provider To Be Named A Category Leader By G2 Crowd Five Quarters In A Row
 
 
 
see-the-demo
 
 

SOME OF THE MOST INNOVATIVE MEDICAL DEVICE COMPANIES IN THE WORLD IMPLEMENT THEIR QUALITY CULTURE USING OUR SOFTWARE

GG-Map
Gabriel Sanchez

We dug deeper to see how other friends we knew were handling their QMS needs and after adding up time, consultant fees, etc. we felt Greenlight Guru was the right tool for the job.

David Narrow

I've been thrilled with my experience working with Greenlight Guru. I am new to quality systems and compliance, and Greenlight Guru has made this transition very easy. The well-organized user interface and tracking features make the software simple and worry-free; I genuinely recommend it to anyone in the indus...

Greg Sommer

Using the Greenlight Guru system has enabled us to better implement our quality system across the company and accelerate our product development.

Linda  Cox

We adopted Greenlight Guru 18 months ago to build our QMS. We recently passed our ISO 13485 Stage 2 audit, due in part to the ability to demonstrate a comprehensive matrix of risk and design controls. Demonstrating our QMS using a tool like GG was fundamental in this achievement. I'll also say that the team at ...

Ryan Shelton

We've been using Greenlight Guru for nearly 5 years now and it really simplifies quality management. It's very easy to get all of our team on the same page and effortlessly trace various efforts through the system. The Greenlight Guru team is one of the best I've ever worked with. They bend over backw...

Mike Fisher

Having 20 years of medical device experience, I have worked with large and elaborate design controls and small and lean design controls. I have also seen the disaster resulting from the absence of appropriate design controls. Greenlight Guru is exactly big enough to ensure compliance but small enough to be easily ...

Ronny Bracken
$20 million might not seem like a lot of money to you, but if you get a $20 million haircut on your valuation because your design controls and quality system aren't up to speed, I guarantee you that's going to hurt. We use Greenlight Guru to avoid that haircut.
Jason Wandersee
I can attest - great company, great people, great solution. They take a significant amount of risk out of medical device companies by creating transparency in the QMS and efficient access for all constituents. Keep up the great work!
Allan Katz
Medical device companies must document Design Controls, yet most struggle with this. Greenlight Guru makes this so much easier for us. Another HUGE headache for medical device companies like ours is document management. And Greenlight Guru helps us take care of this too.
Michelle Zwernemann
The traceability matrix was a huge selling point since I was in the process of trying to train my team on design controls and they had generated spreadsheets that were extremely impenetrable. Also I don't have to run after people to get documents approved. Everyone knows where to look for stuff so I don't have to dig t...
Kate Montgomery
We're all excited to have everything organized and to always know what the correct, most up-to-date version is.
Evan Jones

This is my first time going through a medical device product development process. I've heard about all the challenges with Design Control. With Greenlight Guru, I know what to do and when to do it. Documenting Design Controls is really easy with this software.

Adnan Ashfaq

When it comes to the way they have designed the fully integrated workflows exclusively for medical device and continue to innovate with new releases, I'd call them the Tesla of medical device eQMS software.

Rian Wendling

Greenlight Guru has made the design control and risk management process extremely easy to understand and explain to people not familiar with the process and helped them to understand how all of the steps are linked. It has also made it significantly easier to get documentation reviewed and approved.

Jed Johnson PhD
Greenlight Guru has been instrumental for us moving so quickly through our ISO 13485 certification and I would highly recommend it.
Schelte Post

Your software helped us tremendously in the last few months of 2017, during which we had an important ISO 13485:2016 audit. This obviously reflected on the auditors: it was very easy to show them in what phase every project was, but also to simply show every piece of documentation we have. In the auditors conclusion...

Eric Griffith
I really enjoy the new Greenlight Guru Product! Especially the customer feedback workflow. I like the similarities in workflows between CAPA, nonconformances, audits, and customer feedback. This will improve our abilities to better manage quality events and make better quality decisions.
Dan Holton

I believe the quality system I've instituted actually gives me a competitive advantage against a lot of the large companies I used to work for.

Linda Cox

I was actually a little nervous going into the audit, because it seemed too effortless. I've worked in QA at a Fortune 500 company with a custom solution. Your flow is better. It saves time and it doesn't break up my thought process. With Greenlight Guru I'm able to focus on quality.

Donna Philput

As a design firm, our ISO 13485 certification is a competitive advantage. Greenlight Guru made getting it easy. Our designers aren't accustomed to being under a quality system, but your simple interface made it possible to adopt. It's actually working.

Kyle Rose

A lot of times, if people don't understand quality systems, they think they just want to use paper because it presents as the cheaper option, but they fail to evaluate the total cost of ownership and impact on the business. The biggest differentiator was that it was all web based and didn't need any custom...

“Fantastic Product and Even Better Team”
August 7, 2017

 

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.

 

Download the Customer Onboarding & Training Guide ➞

Customer Onboarding and Training Guide [2020]_Page_13

  • $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

Photonicare-logo-w175

 

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

 

ryan-nolan
Ryan Nolan
Co-Founder & VP of Clinical Operations PhotoniCare

 

 

 

 

c2dx-logo-head

 

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

 

kevin-mcleod
kevin mcleod 
ceo at c2dx, inc

 

 

 

Get your free
quality management software demo

YES, I WANT A DEMO!