Great eQMS for Medical Device Startups
Rating: 8 out of 10
IncentivizedUse Cases and Deployment Scope
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.
Pros
- Design traceability
- Training management
- Risk management
Cons
- 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.
Likelihood to Recommend
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.
JT
Jason Troutner
CTO (Chief Technical Officer) in Engineering at Teal Bio (Medical Device, 1-10 employees)
Vetted Review
6 years of experience