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


Do more value-added engineering work and less

compliance paperwork.


See it in action →


Streamline the management of device requirements, risk, design reviews, and documentation. 
Device submissions are expedited and audit readiness is inherent to the software.
Easily demonstrate traceability between Design Controls and Risk with fully integrated risk management.
Drive accountability and collaboration across distributed teams to assure key development milestones are met.
Enable a renewed focus on developing better medical devices by focusing on value added tasks.
  • 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

Built for medical device product development professionals

design-controls risk-management project-management unified-visibility


Easily manage multi-level device requirements in your traceability matrix and generate a completed Design History File on demand. Create detailed design control objects, link complex configurations, and attach documents with one click. 

See Design Controls in action → 


RELATED EBOOK: Ultimate Guide to Design Controls for Medical Device Companies  Read the eBook




Incorporate risk controls into the product development process with the only cloud-based risk management solution that aligns with ISO 14971:2019. Demonstrate a risk-based approach to design with full traceability to related Design Controls and Components.

See how teams are taking an integrated approach to product risk→ 


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



Meet aggressive deadlines by providing a centralized workspace where one or many teams can see each other's updates in real-time.

With FDA and ISO controls built-in, your team can stop wasting time chasing signatures, documenting offline design reviews, searching through email threads, and dealing with messy design transfers.

See how companies are launching medical devices faster with Greenlight Guru→ 


SUCCESS STORY: How Myolyn gained 510(k) clearance 48% faster than average with  Greenlight Guru  Read the Success Story



Drive accountability by managing device requirements and development efforts in a centralized workspace enabled with added-text formatting to enhance the technical details. Leverage tasks and flexible review and approval workflows to collaborate with internal and external stakeholders. 

See how teams are collaborating with Greenlight Guru→ 


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






 Hardware   Software   SaMD

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

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

Read All Reviews

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...
Read the Full Review
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...
Read the Full Review

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...
Read the Full Review
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 get started doing more value added engineering work and less compliance paperwork?

See the Demo