RISK MANAGEMENT

Stress-free audits
with risks under control

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

An integrated digital approach to risk

icon_question

Challenge

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.

icon_star-2

Solution

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
solutions_design-controls-risks

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
product_design-controls-risk-matrix

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 
solutions_design-controls-risks-panel

Risk management resources

thumbnail-image_audit-readiness-checklist

ISO 13485 risk management plan template

Build a structured medical device risk management plan with our pre-built template.

Get my template
thumbnail-image_mastering_risks

Mastering risks and opportunities webinar

Build a holistic risk management system that squashes risk and harnesses opportunity.

Watch webinar recording

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

icon_Document-management

Document management

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

icon_Design-controls

Design control management

Supercharge your product development from a single source of truth.

icon_Training-management

Training management

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

icon_Change-control

Change control management

Manage change activity easily and effectively with complete traceability.

icon_Audit-management

Audit management

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

icon_CAPAs-Nonconformances

CAPA & NCR management

Build automated response workflows for any quality event.

Icon

Supplier management

Control and categorize suppliers and third parties with complete visibility.

Don't just take our word for it!

Hear from our many happy customers

icon_G2
"Qualio is the best QMS cloud-based system I have ever seen."
Paul H.
Senior VP of Ops, Tech & Quality, Advantice Health
icon_SoftwareAdvice
"When I recommend Qualio, one of the first things I say is: you're going to be able to get this thing in-house, validated, implemented and live in a short amount of time with limited resources.
That's unique in this industry."
Becki N.
Quality & Regulatory Lead, Synthego
icon_LinkedIn
“Qualio has helped make my life as a quality manager very easy.”
Gene V.
Quality Manager, Cirris
icon_LinkedIn
"We looked a lot at how Qualio worked, its user interface, and the technology behind it. It was by far the freshest, most logical eQMS system out there."
Dmitry F.
Chief Technology Officer, ViQi
icon_SoftwareAdvice
"I contacted Qualio in November. We went live mid-December. We had all users in by January. And we had our ISO 13485 certification in July.

Without Qualio, we'd never have done that."
Karen H.
Head of Quality & GxP Compliance, 30 Technology
icon_SoftwareAdvice
"Qualio’s become a verb here. When people need things, Qualio is the word that’s used."
Chris R.
QA Associate, AGADA Biosciences
icon_SoftwareAdvice
"There are other eQMS providers that are very well-established, but not particularly accessible.

Qualio is not overly complicated. It gives us those foundational aspects of a quality system in a way that people can actually get behind."
Phil C.
Quality Manager, Bond Digital Health
icon_G2
"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
icon_SoftwareAdvice
"Me getting back hundreds of hours in a year thanks to Qualio is the equivalent of an 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
icon_SoftwareAdvice
“The cost of our Qualio licenses is insignificant compared to what we've saved by just improving our processes.”
Peter B.
Director of QA, Watchmaker Genomics
icon_SoftwareAdvice
"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
icon_G2
"I entered a world with Qualio where quality is no longer a hassle."
Fedora B.
Co-Head of Biopharma Corporate Finance, JMP Securities
icon_capterra
“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
icon_G2
“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
icon_LinkedIn
"Qualio keeps us in a constant state of audit readiness."
Deb G.
Director of Quality, Dimension Therapeutics
icon_G2
"Qualio is far superior to other
systems I've worked with in the past.
The flexibility has been mind-boggling."
Michael H.
QA Director, TriMed
icon_LinkedIn
"A game-changer for a paper-heavy QMS. Qualio is a breath of fresh air."
Gareth Q.
Director of Quality, iMIX
icon_LinkedIn
"Document control took anywhere from 5 hours to 3 days. Now things get done in hours, even minutes. I can send training out in seconds now. Qualio has made my life 100% better!"
Angela P.
QA Manager, Akadeum Life Sciences
icon_G2
"Qualio helps me sleep better at night.
Having that structure for everyone to work within is essential for us to really succeed this year in getting onto the market and staying compliant."
Heather U.
CEO, EvoEndo
icon_G2
"We passed our MDSAP recertification audit with Qualio!"
John P.
Quality Assurance Manager, KUBTEC Medical Imaging
icon_G2
"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
icon_SoftwareAdvice
"I feel 100% ready in our 510(k) and ISO 13485 preparations.
Qualio let us bring quality in-house in a way that will make us successful."
Hilary B.
VP of Regulatory & Quality, SimBioSys
icon_SoftwareAdvice
"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
icon_SoftwareAdvice
“We’re building a quality product. So we bought a tool that gives us a quality culture. Instead of pushing
quality to one department, Qualio breaks down that barrier.
Daniel A.
Chief Technology Officer, InVivo Bionics
icon_SoftwareAdvice
"When you're using paper, you're not moving forward. You can't.
Now we're so streamlined, we're finally making progress. We're talking about bringing a new product into design controls right now.
I don't think that'd be possible if we didn't have Qualio."
Ami A.
Director of Ops & Quality Management, NeuFit
icon_SoftwareAdvice
"I’ve never been more confident in my 27 years of being audited."
Lowell H.
Director of Quality Assurance, Restech
SEE QUALIO IN ACTION

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