Stress free audits with risk management software

Built on ISO 14971:2019 and ISO 13485:2016, Qualio’s risk management quality system gives you better visibility and consistency across your quality ecosystem. Proactively identify, mitigate, prevent and resolve potential risks before they happen.

The #1 solution that solves today's challenges



Embarking on risk management can be a daunting and confusing as risks are inherent in so many things and processes. Fortunately ISO 14971:2019 exists to provide direction and clarity. Yet many companies struggle to connect risk management to everything else like design and development. This makes developing a risk acceptability matrix (especially with a paper-based system) extremely challenging and time consuming.



Qualio’s cloud-based quality management system connects risk management to design and development activities. Save yourself some time and headache knowing risk management is connected to the entire product lifecycle, giving you visibility to see vulnerabilities across your entire product lifecycle and organization.

See risk vulnerabilities across your entire organization

  • Conduct risk management within Design Controls to mitigate potential problems. 
  • Save time and money by identifying risks early in product development. 
  • Ensure your quality and product teams are aligned on risk activities and vulnerabilities.

Get better visibility into risk with your risk acceptability matrix

  • Define your risk criteria then apply it across your whole quality system, ensuring consistency. 
  • Link risks to your product development design controls and documentation to proactively identify potential risks.
  • Seamlessly get your risk analysis and traceability matrix with one-click.

Manage ISO 14971 or FMEA compliance based on your risk policy

  • Have all your risk management in one place and stay 100% in compliance with ISO 14971:2019 and FMEA. 
  • Define your company’s risk policy and leave the rest of the compliance stuff (including Part 11 signatures) to us.
  • Hands on support and concierge onboarding so you have our team of experts on your side.

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 Cochran
Executive Director of Quality, Linical Americas
“Qualio has helped make my life as a Quality Manager very easy. For the documentation side, as soon as an auditor comes in and audits, they can see everything in the audit trail. Nothing is missing, nothing can be changed without it being documented and the auditors think that is so great.”
Gene Vought
Quality, Cirris
“Having everything in one place. That you can connect or link documents to other documents and keep the traceability of any changes made or decisions made.”
Dragan Velickovski
Software Engineer, Axiom
“Qualio has made it so much easier to review and edit documents prior to document release. This has improved the quality of our documentation and reduced the amount of time spent on getting documents through our release process.”
User in Medical Devices
”I like the very flexible approach that Qualio offers to deal with document type of information. A document can be basically everything from an SOP, over an HR file to an Equipment log. This is very powerful in particular in combination with the tagging feature.“
Christian S
Consultant CMC + QA
“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.”
Sravya D
Medical Fulfillment Specialist

See other features that make Qualio
the #1 top rated cloud QMS


Document management

With Qualio’s secure and cloud-based system, paper files, folders, and spreadsheets become a thing of the past.


Design controls

Qualio’s Design Control accelerates medical device product development by uniting your systems and data in one place.


Training management

Create assessments, assign, report, and track training activity across your company within one platform.


Change control

Qualio’s change control software allows you to manage any change easily and effectively, ensuring compliance and audit readiness.


Audit management

Seamlessly generate reports on activity across your system and your users and set periodic review cadences.


CAPAs & Nonconformances

With Qualio Events, manage pre-defined actions and responses and track in accordance with regulatory requirements.


Learn why we have been ranked the quality management platform of choice