Accelerate your product development while staying compliant

Build products faster with an eQMS purpose-built for software as medical device (SaMD) organizations. Qualio unites your teams and systems in one collaborative environment, while helping you stay compliant with IEC, ISO and FDA regulations.

eQMS for software as a medical device (SaMD) companies



For SaMD teams, building with velocity and delivering quality are often opposing forces. With engineering teams in one system and quality teams in another, ensuring speed and compliance throughout the product life-cycle is nearly impossible.



With Qualio, your teams operate from a single source of truth, so it’s easy to manage traceability, auditability, and compliance. With everyone in one system, you can scale education and training, and speed up your product development process.

Speed up your release cycle

  • Integrate systems like Jira, Azure DevOps, Test Rails, and more for better collaboration.
  • Easily connect data via API to automate your processes.
  • Execute guided workflows for drafting, reviewing, approving, and retiring documents.

A quality platform your team will want to use

  • Straightforward implementation makes onboarding your team fast and easy.
  • Generate release documentation like Requirements Traceability and Risk Analysis Matrices with one click.
  • Assign training based on roles and responsibilities, including in-line assignments.

Minimize risk throughout your development process

  • Enable closed-loop quality within your company with end-to-end traceability across your team’s systems.
  • Create training assessments to maintain quality standards and compliance.
  • Set periodic review cadences to conform to FDA/ISO requirements.

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!

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.
Tyler C
Executive Dir. of Quality, Linical Americas
“The Validation documentation provided by Qualio was easy to understand and execute. I really like the in-app support chat function. It is easy to get in touch with the Qualio team with questions or concerns and the team responds quickly."
Soni M
Director QA/RA, NovoSource
My favorite thing is how Qualio keeps us in a constant state of audit readiness. We chose Qualio as we needed our system to be scalable to support our rapid growth and facilitate quick employee onboarding.
Deb Glancy
Director of Quality
“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
“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
“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

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