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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)-1Leader - Fall21

G2 Crowd 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
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
March 25, 2021
“Simplified Traceability and Risk”
I love how simple the program is and how it takes a lot of time-consuming unnecessary information found in historical QMS systems and replaces it with the critical focused details to move things along quickly.
User in Medical Devices (Mid-Market)
Validated Reviewer
Verified Current User
March 22, 2021
“Great software for QMS activities and document management”
As a small business implementing a QMS for medical device design/manufacturing, it has proven to be an incredibly valuable tool.
Jason C.
Validated Reviewer
Verified Current User
April 1, 2021
“A very good start with GG!”

With Greenlight Guru, I can follow all the steps of our quality management system and make sure all regulatory requirements are met. The most significant benefit for me is being able to accurately verify that all risks are managed and that all design checks are carried out. The software allows us an extremely rigorous follow-up which is and will be a big help for us.

Validated Reviewer
April 1, 2021
“Greenlight Guru has made Design Controls and Project Planning easier to execute and manage”

We are solving document control and design controls with the Greenlight Guru Software. It is easier to release documents and gather signatures for controlled documents. The design controls system has made project management more manageable by having all the documents in one place.

Mike S.
Validated Reviewer
Verified Current User
March 26, 2021
“Demystifying QMS and Regulatory Requirements”

The Greenlight Guru customer success team has helped us navigate the entire process so far, with no ask too large and no question left unanswered. It has by far been one of the best customer service experiences I've had to date.

Kyle P.
Validated Reviewer
Verified Current User
March 16, 2021
“You do not have to do it alone!”

Having come from one of the largest medical device companies globally to a start-up with no QMS, yet alone, an eQMS, the transition to Greenlight has saved my team countless hours and provided an ability, especially during COVID, to do remote approvals of documents, assign tasks, and give visibility to the appropriate team members of a variety of modules in order to collaborate and move forward with pre- and post-market activities.

Adam C.
Validated Reviewer
Verified Current User
March 26, 2021
“Modern QMS Software and Outstanding Customer Service”

#1 - Customer Service! Our Customer Success Manager and Medical Device Guru are both incredibly patient and responsive anytime that my team and I email them questions. They are also genuinely appreciate unfiltered feedback from their customers. Their positive attitudes and attentiveness, specifically throughout our onboarding process, has been instrumental to our success in implementing GG. We did NOT feel like we were left on our own during this process.

Amanda P.
Validated Reviewer
Verified Current User
March 13, 2021
“Greenlight Guru allowed us to get our QMS up and running in less time than we ever thought possible”

The biggest gain for us has been being able to get our QMS up and running from scratch in less than 3 months. It is reassuring knowing that the system helps us to be ISO 13485 and 14971 compliant. We have found GG to be very useful in documenting our design controls and risk matrix. We really like how the system allows you to connect these areas.

Azeret Z.
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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