Great eQMS for Medical Device Startups
June 10, 2022

Great eQMS for Medical Device Startups

Jason Troutner | TrustRadius Reviewer
Score 8 out of 10
Vetted Review
Verified User

Overall Satisfaction with Greenlight Guru

We use Greenlight Guru for all of our Quality Management System needs, including design controls, document control, and risk management. Greenlight Guru allows us to develop our medical device products in a way that is compliant with requirements from the FDA and other regulatory bodies and is easily auditable for both internal and external audits.


  • Design traceability
  • Training management
  • Risk management


  • Occasional non-critical bugs (work isn't saved, documents load slowly, etc.)
  • Some processes take too many clicks.
  • Would love to see in-app support of more file types.
  • Design traceability matrix
  • Document control
  • Change orders
  • Saved a significant amount of consultant time.
  • Removed regulatory and audit risks.
  • Required cash and time investment.
Qualio did not appear to be as robust a solution as Greenlight Guru, and in particular, did not have as strong of design control and risk management capabilities for medical devices. MasterControl was too involved and expensive, and the extra benefits that MasterControl provides were not relevant to us as a startup.

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Todoist: To-Do List & Task Manager, Asana, Xero
Greenlight Guru is the perfect eQMS for smaller medical device companies, especially for users without extensive eQMS experience. I do not know if I would recommend it for larger enterprise customers. The most cost-conscious very early-stage medical device startups might be better off with a paper system, but I am very glad that we had the resources to start with Greenlight Guru from the beginning and did not have to make the switch.


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