Great fit for a software medical device company
May 31, 2022
Great fit for a software medical device company
Score 8 out of 10
Vetted Review
Verified User
Overall Satisfaction with Qualio
We use Qualio as a software medical device quality management system as well as a document management system for other quality and information security applications.
- Is flexible enough to customize for use for different types of medical devices, enabling us to integrate it into our processes and support our quality automation initiatives.
- Supports a distributed/remote workforce by enabling electronic record-keeping and signatures.
- Generally supportive of the quality system regulations we are subject to.
- The search function is poorly implemented and should be improved.
- There is a tendency to rollout new features before they are robustly tested. We would prefer not to be the user acceptance testing.
- Part 11 compliant signatures
- Document version control
- Quality record-keeping
- Provides support for internal audits (which is a challenge for small teams)
- Qualio helped us pass our first MDSAP audit with no findings on the first try.
We selected Qualio over Greenlight Guru because of the flexibility offered in adapting the system to support software as a medical device (SaMD) processes. Greenlight Guru was more expensive and very focused on hardware medical devices which did not fit our needs.
Do you think Qualio delivers good value for the price?
Yes
Are you happy with Qualio's feature set?
Yes
Did Qualio live up to sales and marketing promises?
Yes
Did implementation of Qualio go as expected?
Yes
Would you buy Qualio again?
Yes