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.


#1 Solution for Today's Risk Management


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

  • Save time and resources by utilizing our expert quality team.
  • Get up and running quickly and through validation in record time.
  • End-to-end concierge service from SOPs, gap assessments, to internal/supplier audits and more.

Learn more about Qualio Plus >>

Don’t take just our word for it.

“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, Ultragenyx

“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

“The changelog in Qualio has been particularly helpful. We can print it out and give it to the auditor to show we’re still compliant since we validated two years ago, for example.”

Irisys Adolfo Ramirez
Director of Information Systems and Data Compliance

See other features that make Qualio the #1 Top Rated Cloud QMS.

Document Management

Training Management

Design Control

Change Control

CAPAs & Nonconformances

Audit Management

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