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?

Anonymous | TrustRadius Reviewer
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.

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Did Qualio live up to sales and marketing promises?


Did implementation of Qualio go as expected?


Would you buy Qualio again?


Very suited to managing documents and records although cannot download word versions of documents and records but can with forms.
Well suited to managing D&D and risk assessments.
Not so good at managing training or suppliers.