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“Greenlight Guru has been instrumental for us, as a small team, while we efficiently navigate the quality management system process and with developing our FDA submission.”
- Ryan Nolan, Co-Founder / VP of Clinical Operations Photonicare


Device Class: I, II, III
Segment: Redacted
Device Class: II
Segment: Gynecology, Diagnostics
Device Class: I, II, III
Segment: Multiple
Device Class: II
Segment: Gastroenterology
Device Class: II
Segment: Vascular, Patient Management: Monitoring, Biomaterials
Device Class: I, II, III
Segment: Multiple
Device Class: II
Segment: Orthopedics
Device Class: I, II
Segment: Vascular, Pain Management
Device Class: II
Segment: Cell Therapy, Biomaterials
Device Class: II
Segment: Ears
Device Class: II
Segment: Respiratory, Orthopedics, Cell Therapy, Biomaterials
Device Class: II
Segment: In Vitro Diagnostics
Device Class: II
Segment: Healthcare Technology/Digital Therapeutics
Device Class: I, II
Segment: In Vitro Diagnostics
Device Class: I
Segment: Dental Implants

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G2 provides real-time and unbiased user reviews to help you objectively assess what software is best for your business.

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August 7, 2017
“Fantastic Product and Even Better Team”
The GG team goes out of their way to help us meet our business objectives. They are knowledgeable in the regulatory and quality management space and are always trying to improve their software and user experience.
Ryan Shelton
Validated Reviewer
Verified Current User
November 21, 2021
“Finally...eQMS software I have confidence in”

An efficient and controlled way of managing our documentation is now much more straightforward. I am confident that we are compliant with using GG

Kelly W.
Validated Reviewer
Verified Current User
November 19, 2021
“An Intuitive, Supportive, and Forward-thinking E-QMS”

Greenlight Guru are ahead of the game in terms of incorporating workflows which lead to compliance to ISO 13485:2016 and 21 CFR Part 820 regulations. The Change Management and Document Control functionalities make it easy to control records and document approvals especially in a world that is moving away from the traditional 'in-office' setting to remote working

Jacob S.
Validated Reviewer
Verified Current User
November 18, 2021
“User friendly eQMS that comes with a great team”

The software is user-friendly and customizable enough to meet your needs if you already have an existing QMS set up. But honestly, the best part is the team we work with for our transition process. They make the difference in this being a good experience. Their friendliness and wealth of knowledge about the medical device industry made the process so easy

Validated Reviewer
Verified Current User
November 17, 2021
“From Paper to electronic in less than 6 months”

With Greenlight Guru, we have been able to solve training gaps, on-time completion of customer complaints and non-conformances, and change orders. Previously to Greenlight, we had complaints that sat uncompleted for over a year; now with GG we are able to close them in less than 30 days.

Stacy M.
Validated Reviewer
Verified Current User
November 10, 2021
“Documentation and Collaboration Made Easy”

Greenlight Guru is life-changing! The platforms for documentation and collaboration have made me and my team so much more efficient. It has turned the huge headache of regulatory compliance into a much more manageable task.

Courtney L.
Validated Reviewer
Verified Current User


Gabriel Sanchez
Gabriel Sanchez, CEO
Zebra Medical Technologies

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
David Narrow, CEO
Sonavex, Inc.

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
Greg Sommer, CEO & Co-founder
Sandstone Diagnostics, Inc.

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

Linda  Cox
Linda Cox, SVP QA/RA

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
Ryan Shelton, CEO

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
Mike Fisher, Director of Product Development
GCMI (Global Center for Medical Innovation)

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
Ronny Bracken, COO
Nanofiber Solutions
$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
Jason Wandersee, Former CEO
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!
Joe Hage
Joe Hage, Leader
Medical Devices
When it comes to quality management software for medical device companies, they are simply the best in the space.
Allan Katz
Allan Katz, CEO & President
Long Island Technology Group
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
Michelle Zwernemann, Director of Product Development
infinite biomedical technologies
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
Kate Montgomery, Lead R&D Scientist
Zebra Medical Technologies
We're all excited to have everything organized and to always know what the correct, most up-to-date version is.
Evan Jones
Evan Jones, Product Development Engineer
Long Island Technology Group

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
Adnan Ashfaq, Director
Pharmi Med Ltd

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
Rian Wendling, Director of Regulatory Affairs

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
Jed Johnson PhD, CTO
Nanofiber Solutions
Greenlight Guru has been instrumental for us moving so quickly through our ISO 13485 certification and I would highly recommend it.
Schelte Post
Schelte Post, Quality Manager
MR Coils

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
Eric Griffith, Senior Product Development Engineer
Recovery Force
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
Dan Holton, Founder & CEO
Cypris Medical

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
Linda Cox, Senior Vice President QA

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
Donna Philput, Senior Quality/ Regulatory Specialist
Priority Designs

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
Kyle Rose, President
Rook Quality Systems

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...

Amir Fassihi MD
Amir Fassihi MD, Founder & CEO
Amnion Life

A highly complex medical device like the Amniobed requires a very complex design control, quality management and risk assessment analysis to meet the toughest worldwide regulatory standards. We are excited and proud to be working with Greenligh Guru.

Evan Luxon
Evan Luxon, Co-Founder & CEO

Those at Greenlight Guru are thought leaders when it come to quality management systems in the medical device industry. I have a high degree of confidence that as changes to the regulations occur, I won't have to worry about being out of compliance because we are using Greenlight Guru.

Tonia Bryant
Tonia Bryant, Director of Quality/Regulatory

I highly recommend Greenlight Guru. They have taken a complex industry and made it into a product that is simple to use.

Lynsie Thompson
Lynsie Thompson, Quality and Regulatory Lead

With Greenlight Guru, you've got software, but also what amounts to a personal consultant. Those connections are powerful.

Kevin McLeod
Kevin McLeod, CEO
Critical Care Diagnostic, Inc.

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

Kevin Coker
Kevin Coker, Co-founder & CEO
Proxima Clinical Research, Inc.

There is a transactional cost to implementing an eQMS system, that in my opinion grows 10x every year a company delays.

Daniel Powell
Daniel Powell, CEO
Spark Biomedical

You guys make sure this system aligns with what the government wants. I had a whole team on staff when I was at a Fortune 500 medical device company and they didn’t know what design validation was…so with that knowledge, you guys are saving me $100k a year in terms of cutting headcount.

Ankitha Rajagopalan Nair
Ankitha Rajagopalan Nair, Manager of Regulatory Affairs
Aidar Health

Without your support, we would have not gotten to where we are currently…thank you so much for advising us in all matters regarding quality and regulatory…and for providing us with such a comprehensive platform for our quality system and for facilitating our interactions.

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