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Empower your team with a software platform that accelerates device clearance timelines

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Accelerate product development efforts and improve the quality of regulatory submissions
Leverage quality as a strategic advantage to protect your brand and impact the top and bottom lines
Grow faster with a quality system that allows you to scale and navigate different international markets
Achieve peace of mind knowing your quality system can stay ahead of compliance changes
Proactively identify and reduce risk



  • 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

Medical Device Quality management software that enables a culture of true quality and accelerates outcomes

traceability-edit-01 audit-readiness Premarket-Quality-Management-Software-go-risk-management-screenshot usability
Audit Readiness


With a fully connected QMS that incorporates design controls and risk, your team can assure traceability throughout the product lifecycle in order to expedite device clearance timelines and navigate audits with ease.

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



Drive collaboration in a centralized workspace for managing device requirements, risk, documents, & quality activities while leveraging Part 11 compliant review and approval workflows to collaborate with internal and external stakeholders. 

See how teams are collaborating with Greenlight Guru to accelerate outcomes →  


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

Risk Management


Mitigate the likelihood of missed product development milestones or regulatory delays in achieving device clearance. By taking a proactive approach to managing risk activities over the course of the product lifecycle, your team will be positioned to drive higher quality outcomes for patients and partners. 

See how teams are controlling patient and business risk → 


RELATED EBOOK: The Definitive Guide to ISO 14971 Risk Management for Medical  Devices  Read the eBook



With a turn-key medical device quality software platform that offers audit-proven quality templates, built-in controls, medical device expert services, and a modern interface that is easy for teams to learn and use, your team can focus on value added activities that lead to efficient growth.

Learn how innovative teams are scaling quality → 


The low risk quality system powering high growth medical device companies around the globe

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

Ready to learn more about how your team can accelerate outcomes and leverage quality as a strategic advantage?

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