Bring high quality medical devices to market faster

Develop better life-saving products with an eQMS purpose-built for medical device companies. Qualio streamlines your medical device product development while helping teams stay compliant.

eQMS for medical device companies



Many medical device companies work in multiple systems that create a siloed approach to quality management; some have a unique module for CAPAs or a separate tool for design controls. Others are stuck in paper-based solutions that need constant revalidation. These approaches don't scale, and slow down the release of innovative, life-saving products patients need.



With Qualio, your quality management system is built on flexible workflows and templates, so your quality processes grow as you add more products. Seamlessly migrate your legacy systems into an all-in-one, cloud-based platform that your team can use from anywhere. Stay compliant with automated reporting audit trails, training and change control.

Easily scale from prototype to production

  • Ensure quality with a single, easy-to use platform that grows with your company.
  • Connect your product development stack to Qualio for collaboration across teams.
  • Execute workflows for document approval, design controls, training and more.
  • Manage suppliers, audits and change control across your entire business in real-time.

Building products is hard, using Qualio isn’t

  • Easy implementation makes onboarding your team fast and painless.
  • Digitize your documents and collaborate on files with our simple web editor.
  • Organize and search your document library to find what you need when you need it.
  • Quickly generate release documentation with a single click.

Successfully navigate complex regulations

  • Easily comply with ISO 13485 , ISO 14971 and 21 CFR Part 820 and Part 11.
  • Connect risk management to all design and development activities, so you can see vulnerability early.
  • Maintain a clear audit trail and end-to-end traceability for all product information.
  • Get expert advice from our best-in-class quality advisors.

Have quality and regulatory
experts on your side

Add Qualio+ to any plan and receive expert quality assurance
support to help growing companies get to market faster.

Regulatory content

Pre-configured templates and pre-written documentation for FDA & ISO compliance.


Quality assurance experts

Access to our team of quality experts to ensure you meet and exceed your QA goals.

Don't just take our word for it!

Qualio has been super helpful to us feeling like we have all the pieces in place for quality management an FDA standard.
Jen Baird
CEO, Fiftheye
I would recommend Qualio to small companies implementing a quality system for the first time. Qualio helped us to reduce workload and paper trail.
Paul Maguire
CEO & Co-Founder, Arann healthcare
We evaluated all players on the market ... and came up with Qualio as the best balance of price, capability, and quality of support. Really like the change event management, API flexibility, training tracking, and customer success support.
Jeffrey B
CFO, Fiftheye
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.
David Hughes
CEO, Surfatek
For those just starting out, the Qualio Plus service fits right in to ensure a smooth transition to a new eQMS. Their diligent team has helped ensure our QMS implementation was smooth and effective, offering excellent advice every step of the way.
Chris Sloane
Quality Manager, CureMetrix
A digital trail is so important in medical devices, particularly around field servicing and updating. It is just lovely to know that you have these automatic links and alerts, so you know that two years from now and you are looking back, you will find it.“
Andrew Levien
President and CEO, ArcScan

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