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Medical Device Quality Management Software (MDQMS) that Gets You To Market Faster.


fast to implement
scales with your team
simplifies compliance

Built by medical device professionals, for medical device professionals. Our QMS software workflows align to FDA & ISO standards for medical device predefined processes

  • 21 CFR Part 11 Compliant
  • FDA 21 CFR Part 820
  • ISO 13485:2016
  • ISO 14971








Integrated Design Control

Maintain full design traceability by creating and updating your traceability matrix in minutes, not hours or days. With Greenlight Guru's medical device QMS, you can create your design control objects, link complex configurations, and attach related documents with a single click.








Minimize Risk

Integrate risk management into your entire quality management system right out of the box. You’ll spend less time and money fixing issues that expose you to risk when you can catch them earlier and have complete visibility.


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Document Management

With Greenlight Guru's medical device QMS, managing signatures, documents, audits, and inspections is a breeze with our quality management software. No more chasing signatures, manually routing documents, working off the wrong version, and sweating audits. Everything is easily accessible and in one place. 








Streamline CAPA Process

Within our medical device quality management system (MDQMS), your team can effectively manage your risk-based CAPA process in a connected ecosystem where inputs and outputs tell the true story.








Reduce Nonconformances

Leverage our QMS to reduce non-conformance cycle times and the risks associated with your nonconformance. 








Faster Audits

Conduct internal and external audits, route findings based on risk, and easily share results in an easy to use quality assurance software interface.








Customer Feedback

Streamline a customer feedback and complaint processes with our medical device QMS software to align with FDA regulations. Quickly determine whether feedback requires immediate action or the issuing of a CAPA.








Change Management 

Our industry-leading quality control software manages and communicates the impact of any change. Connect, better evaluate, and trace the impact of changes.








Assign Training

Get the right training to the right people at the right time. Assign training to individuals, set due dates, and keep track of tasks to ensure training completion. 

4.5/5 stars on Capterra
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4.5/5 stars on G2 Crowd
“We've been using Greenlight Guru for the better part of three 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. ”
Ryan Shelton, CEO