Get your medical device
to market faster with #1-rated design control software

Pull your device design data together and stamp out risks.
Focus on building a great medical device - without the
headache of manual compliance work.

Streamline your design controls with smart software



Quality teams work in one system. Engineering teams in another.

Siloed and disconnected teams and platforms make traceable, compliant product development impossible to manage.

Work grinds to a halt, quality and development work against each other, and your path to market becomes a complex nightmare.



Qualio's design control software offers a single source of truth for all your product development activities.

Pull product data into Qualio with integrations. Control inputs, requirements and risks. Bring your quality and engineering teams into sync.

All underpinned by a complete, compliant document stack to show your auditors.

Unite systems and data to enable effective collaboration and stop delays

  • Demolish quality and engineering siloes by connecting systems like Jira, Azure DevOps and TestRail to Qualio
  • Build a real-time, always-up-to-date document stack that flows seamlessly from your engineering team to quality 
  • Centralize all design control data by product, from requirements to inputs, outputs, risks and drag-and-drop attachments

Maintain end-to-end traceability across systems in real time

  • Easily pinpoint missing tests, risk mitigations and more for a right-first-time approach
  • Drive changes and product updates quickly and easily
  • Unlock 100% traceability across design elements while your engineering teams work in the source systems they know and love

Generate release documentation with one click

  • Easily produce quality documentation to ensure you’re delivering a safe and effective product, eliminating time-consuming paper-based processes and manual governance
  • Be 100% audit-ready at all times with documentation, e-signatures and objective evidence
  • Access automated snapshots of product documentation, like a Change History Report, for each stage of your product lifecycle

Design control software purpose-built for your quality and product teams


Quality teams...

... for medical device, SaMD and SiMD companies enjoy a single source of truth for design controls and product data.

Export automated documentation, embed FMEA and ISO 14971 risk management and unlock complete traceability from input to output.


Product teams...

...enjoy uninterrupted development as the engineering systems they're used to are linked directly to Qualio.

Develop and innovate, safe in the knowledge that your work is flowing accurately and in real time straight to the quality department.

Design controls management resources


Ultimate guide to medical device design controls

Become a design controls expert and start applying the 9 core elements of medical device design controls with our comprehensive breakdown guide.

Get my guide

Design controls datasheet

Learn how Qualio Design Controls combines powerful functionality with ease of use for a controlled, compliant pathway to market that meets ISO and FDA requirements.

Get my datasheet

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. 


Risk management

Detect and mitigate risks and comply with
ISO 14971 and ICH Q9.


Supplier management

Control and categorize suppliers and third parties with complete visibility.


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 the best QMS cloud-based system I have ever seen."
Paul H.
Senior VP of Ops, Tech & Quality, Advantice Health
"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
“Qualio has helped make my life as a quality manager very easy.”
Gene V.
Quality Manager, Cirris
"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
"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
"Qualio’s become a verb here. When people need things, Qualio is the word that’s used."
Chris R.
QA Associate, AGADA Biosciences
"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
"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
"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
“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
"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
"I entered a world with Qualio where quality is no longer a hassle."
Fedora B.
Co-Head of Biopharma Corporate Finance, JMP Securities
“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
"Qualio keeps us in a constant state of audit readiness."
Deb G.
Director of Quality, Dimension Therapeutics
"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
"A game-changer for a paper-heavy QMS. Qualio is a breath of fresh air."
Gareth Q.
Director of Quality, iMIX
"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
"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
"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
"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
"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
“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
"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
"I’ve never been more confident in my 27 years of being audited."
Lowell H.
Director of Quality Assurance, Restech

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