Great eQMS for Medical Device Startups
Use 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.
Most Important Features
- Design traceability matrix
- Document control
- Change orders
Return on Investment
- Saved a significant amount of consultant time.
- Removed regulatory and audit risks.
- Required cash and time investment.
Alternatives Considered
Qualio and MasterControl Quality Excellence
Other Software Used
Todoist: To-Do List & Task Manager, Asana, Xero
