An eQMS tailored for the life-sciences industry

About Qualio

Qualio is an eQMS tailored for the life-sciences industry. With a ready-to-use, flexible quality management system that unites teams, processes and data in one place - Qualio helps organizations get to market quickly and scale successfully.

Trusted by life science and healthcare organizations around the globe, Qualio is the trusted quality platform for:

  • Medical device and SAMD/diagnostic companies
  • Biotech/therapeutic companies
  • Contractors (design, development, manufacturing, lab, research) for the above industries
  • Pharmaceuticals

Qualio software can scale with your company and is applicable for small, medium, and enterprise organizations.

Video Overview


Quality platform with:

  • Design Controls: Supercharge your product development from a single source of truth.
  • Training Management: Build a competent, confident, compliant, continuously improving workforce.
  • Audit Management: Make compliance and audit readiness the natural core of your business DNA.
  • Document Management: Make paper, filing cabinets, folders and spreadsheets a thing of the past.
  • Risk Management: Master your risk environment, detect and mitigate risks and comply with ISO 14971 and ICH Q9.
  • Supplier Management
  • Events for CAPAs and Nonconformances

Change Control capabilities, native integrations and additional Qualio+ services are available to ensure you get support from quality experts.


Qualio is available as a subscription-based solution. The platform is $12,000 to start and $3,000 per user. The platform subscription includes all software in the package and up to 10 users. Any additional users can be added for a low annual fee. There is no free trial available.


Qualio integrates with your most important apps, so you can spend less time on manual tasks and more building a single source of truth.

  • Asana
  • Azure DevOps
  • TestRail
  • Okta
  • Jira
  • Azure/Office365
  • Qualio’s Public API
  • Salesforce
  • Google Suite

Product Overview

User Reviews of Qualio

Submitted on March 25th, 2022 by Jen Baird from FifthEye

Qualio has been super helpful to us feeling like we have all the pieces in place for quality management system… to an FDA standard.

Submitted on March 25th, 2022 by Paul Maguire from Arann Healthcare

I would recommend Qualio to small companies implementing a quality system for the first time. Qualio helped us to reduce workload and paper trail.

Submitted on March 25th, 2022 by David Hughes from Surfatek

Qualio enabled us to seamlessly work through the ISO 13485:2016 requirements and design errors out of our quality management system. One way Qualio achieves this is to ensure that changes flow through our system and are applied globally.

Submitted on March 25th, 2022 by SoniM from NovoSource

The validation documentation provided by Qualio was easy to understand and execute. I really like the in-app support chat function-it’s easy to get in touch with the Qualio team with questions or concerns and the team responds quickly.

Submitted on March 25th, 2022 by Dr. Heather Underwood from Evoendo

It’s been a pleasure to work with Qualio.

Submitted on March 25th, 2022 by Sravya D from Medical Fulfillment Specialist

The best thing I like about Qualio is how simple the documents are prepared for easy understanding by anyone who has no knowledge on what they’re reading, be it a policy or a basic learning document.

Submitted on March 25th, 2022 by Tyler Cochran from Linical Americas

You can look at an SOP in Qualio, see the list of associated documents, and click hyperlinks to retrieve information immediately. That’s one feature I’m greatly enjoying.

Submitted on March 25th, 2022 by Nicole H. from Aytu BioPharma

I love Qualio… The most user-friendly system that I’ve ever used in my whole career.

Submitted on March 25th, 2022 by Marija K. from Eton Pharmaceutical

Qualio has different modules all in one. No need to have different QMS software.

Submitted on March 24th, 2022 by Sam Dribin from CureMetrix

Qualio has helped us tremendously with the QMS and getting started.