Stress-free audits
with risks under control

Proactively identify, mitigate, prevent and resolve risks before they happen.

An integrated digital approach to risk



Risks lurk in every nook and cranny of your business. Pinpointing and tackling every single one is extremely difficult.

And when you do get a risk management system in place, it doesn't always integrate with your product design and development processes - leaving crucial risks undetected and unresolved as you get to market.



Qualio embeds risk management into the heart of your product design and development activities.

Total visibility, bespoke action workflows and automated document stack creation removes the effort and headache of risk management and lets you bring a safe, compliant product to your patients and customers.

Detect vulnerabilities across your entire organization

  • Build a single source of truth for risk identification, monitoring and remediation
  • Save time and money by identifying risks early in product development
  • Align your quality and product teams around risk and vulnerability activities

Unlock deep risk visibility with an acceptability matrix

  • Define your risk criteria then apply them across your whole quality system
  • Link risks to your product development design control and documentation processes to squash risks for a right-first-time approach
  • Seamlessly access risk analysis and traceability matrices with one click

Embed ISO 14971 and FMEA

  • Build automatic ISO 14971 and FMEA compliance into your medical device design controls
  • Show complete risk control to your auditors
  • Export risk records and link risks to CAPA plans and Qualio documents 

Risk management resources


Design controls software datasheet

Learn how Qualio Design Controls provides controlled, consistent ISO 14971 risk management for your medical device development.

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Event management software datasheet

See how Qualio Events arms your life science business with a robust and proactive response to risks, from CAPA workflows to deep reporting.

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


Document management

Make paper, filing cabinets, folders and spreadsheets a thing of the past.


Design control management

Supercharge your product development from a single source of truth.


Training management

Build a competent, confident, compliant, continuously improving workforce.


Change control management

Manage change activity easily and effectively with complete traceability.


Audit management

Make compliance and audit readiness the natural core of your business DNA.


CAPA & NCR management

Build automated response workflows for any quality event.

Don't just take our word for it!

Hear from our many happy customers

"Qualio is a superb eQMS solution for medical devices."
Andrew R.
Director of Tech & Quality, Medbaye
"Qualio is the best QMS cloud-based system I have ever seen."
Paul H.
Senior VP of Ops, Tech & Quality, Advantice Health
"I joined in November 2020. I contacted Qualio 2 weeks later. We went live mid-December. We had all users working in the system by the January. And we had our Stage 2 certification by July.

Without Qualio, we'd never have done that."
Karen H.
Head of Quality & GxP Compliance, 30 Technology
“Qualio has helped make my life as a quality manager very easy.”
Gene V.
Quality Manager, Cirris
"Qualio is flexible and easily adaptable with excellent auditing features."
Tom D.
Quality Engineer, Carestream Health
"I'm wearing about sixteen hats here. So me getting back hundreds of hours in a year thanks to Qualio is the equivalent of about one FTE. 

Qualio has given us one more staff member in a company where we throw nickels around like manhole covers!"
Mike T.
VP of IT & Information Security, xCures
"The perfect QMS system for a start-up. Everything, from validation to migration and training, was a positive experience."
Drew M.
Director of Quality, ECM Therapeutics
“Qualio gives me everything in one place. I can connect or link documents to other documents and keep the traceability of any changes made or decisions made.”
Dragan V.
Software Engineer, Axiom
"The Qualio team made a big difference to our company by providing amazing help and guidance at a critical time in our QMS development."
Jackie L.
Managing Director, Auxilio Pharmaceuticals
"Set-up is easy and very user-friendly.  Qualio gets rid of the paperwork. Simple to use, affordable."
Rachel A.
Medical Outreach Specialist, eHealth Technologies
“We evaluated all players on the market and came up with Qualio as the best balance of price, capability, and quality of support.”
Jeffrey B.
CEO, FifthEye
“Once you understand how Qualio works, it's really easy to plan out processes and put them into place within the QMS.”
Sara V.
Quality Manager, Leaseir Technologies
"My favourite thing is how Qualio keeps us in a constant state of audit readiness."
Deb G.
Director of Quality, Dimension Therapeutics
"Any intelligent person would look at Qualio and say, "This is exactly what a cloud-based system should do". But when you actually see it in action, you still think it's pretty cool."
Andrew L.
CEO, ArcScan
"A game-changer for a paper-heavy QMS. Qualio is a breath of fresh air."
Gareth Q.
Director of Quality, iMIX
"I would recommend Qualio to small companies implementing a quality system for the first time. Qualio helped us reduce our workload and our paper trail."
Paul M.
CEO, Arann Healthcare
"Qualio+ fits right in to ensure a smooth transition to an eQMS. The team offered excellent advice every step of the way."
Chris S.
Quality Manager, CureMetrix
"We needed something that was user-friendly, easy to onboard and easy to get up and running. Qualio has surpassed our expectations on those metrics."
Stephana P.
VP of Quality, Alphazyme
"The validation documentation provided by Qualio was easy to understand and execute. I really like the in-app support and chat function."
Soni M.
QA/RA Director, NovoSource
"We passed our MDSAP recertification audit with Qualio!"
John P.
Quality Assurance Manager, KUBTEC Medical Imaging
"Qualio has been great to work with. We implemented an entire QMS with them! Intuitive functionality, friendly staff."
Kim K.
Executive VP of Operations, VirTrial
"A big step up for our small company. Much easier than digging through a file repository manually!"
Matt S.
Senior Software Engineer, ArcScan
"Now that we’re electronic, we can grow to 500 or 1,000 employees.
Since we don’t need to grow the QA team as much, we can put more resources into employees who make us money, like scientists and manufacturing personnel."
Adolfo R.
Director of Information Systems & Data Compliance, IRISYS
"With other vendors, we felt like just a number.
But this is like a true partnership. Qualio has definitely changed our world."
Eric D.
Director of Quality Assurance, Expression Therapeutics
Qualio enabled us to seamlessly work through our 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 H.
CEO, Surfatek
"The impact was immediately felt in terms of version management and training. Qualio simplified things immensely."
Andrew B.
Director of Quality Assurance, VitaCyte
"Qualio shows we're taking quality seriously and investing in quality improvement initiatives.

We plan to keep growing with Qualio, offering visibility, continuous improvement and knowledge management to our current and potential customers."
Edgar G.
Quality Assurance Specialist, The Dot

Learn why we're ranked the quality management platform of choice