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A connected quality ecosystem where every record of your QMS is organized, centralized, and traceable


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It's the leading QMS designed specifically for the medical device industry, enabling a new way to manage your quality program.
Track and manage quality events and associated follow up tasks digitally.
Capture usable quality metrics in real-time.
Assure your team's documentation is audit ready in real time.
Drive traceability throughout your quality, design, and risk processes.



  • 21 CFR Part 11 Compliant
  • Workflows aligned to FDA and ISO standards for medical device predefined processes
  • FDA 21 CFR Part 820
  • ISO 13485:2016
  • ISO 14971:2019
QE Automation

Automate your quality event workflows

Avoid the rework and excess documentation involved with each new quality event opened, by implementing custom CAPA, Nonconformance, Customer Feedback, or Audit workflows to automate the step-by-step process.

Increase your team’s efficiency when managing post-market quality events with custom-built, automated workflows while still working within the guardrails of Greenlight Guru.

The connected quality platform built

for medical device companies

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Simplify Quality Processes 

Enable a culture of quality by managing quality events like CAPA, Customer Feedback, and Audits in Workspaces with 21 CFR Part 11 compliant review and approval workflows to collaborate with internal and external stakeholders

See how teams are streamlining quality processes → 


SUCCESS STORY: How SimplicityMD used Greenlight Guru to explain complex  processes  Read the Success Story



Easily incorporate ISO 14971:2019 compliant risk-based controls into your quality and design processes throughout both development and post-market surveillance stages.

See integrated Risk Management in action → 



Assure traceability throughout the product lifecycle by easily linking post market activities to Design Controls, Risks, and Documents 

See it in action → 


RELATED WEBINAR: FDA partners with Greenlight Guru: Case for Quality webinar  series  Listen to the Webinar



Speed up reviews and approvals by keeping your documents, records, and procedures organized, up-to-date and always accessible to the right people with robust sharing and role based security.

See Advanced Document Management in action → 



G2 - Spring 2020 (1)-1G2 Spring 2021 Leader

G2 Crowd 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

See how our software enables a culture of true quality and accelerates outcomes 

See the Demo