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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
March 19, 2018
“Delighted with Both the Product and the Service”

We searched for a digital solution to see if one was available after being told that only paper-based systems would satisfy FDA. We found Greenlight Guru and have been delighted with both the product and the service. Greenligh Guru gives us a digital QMS so that we can safely launch our first four products. We feel confident our system can withstand any FDA audits.

Thomas Gardner
Validated Reviewer
Verified Current User
April 2, 2018
“Great eQMS system with Great Customer Support team”
Greenlight Guru is always listening to customer's voice and making improvements to the software. The Customer Support team is also very helpful whenever I have questions about how the software works. Once setup, it reduces the time it takes to maintain the Quality System or prepare for an audit.
James Wu
Validated Reviewer
Verified Current User
April 24, 2018
“Design Controls Lifesaver!”
The design controls & risk management platform is beautiful. It saves a ton of time updating design controls and risk management inputs & outputs that would normally require multiple document updates with each change. This platform makes it so easy to document and capture the whole design & risk management process so easily. Consider the business savings to having all document control, risk management, and design controls at your fingertips and not requiring paper solutions. This platform removes the frustration of giant excel documents that inevitably fail to be properly updated. It usually t...
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Christie Johnson
Validated Reviewer
Verified Current User
April 24, 2018
“Great eQMS Software”
The software is easy to use with little to no customization needed. It has been a great tool for developing our device through design control. The post-market additions have been amazing as well as tasks. After using multiple types of eQMS software over the years this is the best by far! Quality system related activities such as revision control, storage, and validation are easily tracked and completed within the software. We also have a team of engineers around the country so using Greenlight Guru for design and risk has improved our collaboration and efficiency.
Validated Reviewer
Verified Current User
April 26, 2018
“Wonderful eQMS and Team! ”

The DC and Risk matrices make Greenlight Guru a great software for medical device companies. The ability to link the design controls and risk elements together allow companies to develop safe and effective devices. The application also allows our teams to work together from different locations in order to accommodate everyone's schedules! The Greenlight Guru software keeps a log of all changes made in the system. This means each time a user views, edits, approves, rejects, etc. an input in the software, the data is captured and can be pulled for reference. This allows for traceability...
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Consultant in Medical Devices
Validated Reviewer
Verified Current User
May 11, 2018
“My QMS is World Class”

The software allows me to mitigate my regulatory and compliance risk, I have been able to implement a world class eQMS that rivals the largest companies in med device. Greenlight has the best in class support, it is both software and service.

Dan Holton
Validated Reviewer
Verified Current User
May 22, 2018
“One Stop Shop for MD QMS”
I love that everything is 'under one roof', the design, document control, training, change management, NC,s CAPAs, Feedback and Audits. I really love the risk within design, it is set out clearly, easy to use and clear to see the risks at a glance. I also love that Greenlight have a continual improvement approach and new features being added to enhance the usability and performance from time to time. Also, their customer service is top class. I really don't know how I would do my job without it!
Maria McGrady
Validated Reviewer
July 18, 2018
“Medical Device QMS system compliant and ready to use out of the box”
Greenlight Guru is fully focused on medical device manufacturers. As a result, it provides ISO 13485 and FDA QSR compliant methods out of the box with no setup. It is also deployed and maintained by GG reducing any associated hassle. In addition, they provide validation protocols and reports which eliminates that obstacle as well. Overall there is almost no overhead in using this system (installation, backup, updates, validation are all covered by GG) while it does remove a lot of the overhead of a paper system. It is straightforward in use and functionality is continuously added to cover more...
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Niels Festjens
Validated Reviewer
Verified Current User
August 3, 2017
“Positive Greenlight Guru Experience”

Real time reviewing and publishing of quality documents. GUI of website makes it very easy to navigate without any hassle.

Kevin N.
Validated Reviewer
Verified Current User
August 4, 2017

The support at Greenlight Guru has been incredible. There is live chat available and any question [is answered] in a matter of minutes! This extends beyond just how does system support. Greenlight Guru is able to answer questions related to ensuring that your system is compliant to the necessary standards required for medical devices.

Administrator in Consumer Goods
Validated Reviewer
August 3, 2017
“Easy to Use”

Easy to upload, organize, and find documents

User in Biotechnology
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.

Want to learn more about our Postmarket Quality Management software? Let us show you around Greenlight Guru.

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