How does Qualio stack up as an eQMS solution for QMS implementation for medical devices?
May 25, 2022
How does Qualio stack up as an eQMS solution for QMS implementation for medical devices?
Score 7 out of 10
Vetted Review
Overall Satisfaction with Qualio
The company is a startup with no prior experience with medical device development or quality management. It is being implemented to support ISO 13485:2016 and 21 CFR 820 certifications for obtaining CE for EU and ARTG listing in Australia. The scope is a full implementation, training, and maintenance, and as a consultant, I have been given that responsibility.
- Document and record control
- Risk management
- Design and Development
- Attachment of records without need to change revisions or keep in Draft
- Training records for groups
- CAPA escalation process and review of metrics
- Relative ease of use
- Cost
- Training and help provided by Qualio
- Provided a platform to develop a robust ISO 13485 compliant QMS.
- Speed of implementation.
- Good ROI and reduction in human resources for managing the QMS compared to other eQMS solutions.
Much better suited to a small start-up environment than Green Light Guru. Less suited in terms of usability compared to Q Pulse which has more bespoke configuration options, is easier to configure, and has more modules that interact with each other. Have tried Q Pulse and Green Light Guru.
Do you think Qualio delivers good value for the price?
Yes
Are you happy with Qualio's feature set?
No
Did Qualio live up to sales and marketing promises?
No
Did implementation of Qualio go as expected?
No
Would you buy Qualio again?
No