Great eQMS for Medical Device Startups
June 10, 2022
Great eQMS for Medical Device Startups
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.
Do you think Greenlight Guru delivers good value for the price?
Yes
Are you happy with Greenlight Guru's feature set?
Yes
Did Greenlight Guru live up to sales and marketing promises?
Yes
Did implementation of Greenlight Guru go as expected?
Yes
Would you buy Greenlight Guru again?
Yes