The #1 cloud-based quality
management system for life sciences

Qualio’s ready-to-use QMS unites your teams, processes and data in one
place - so you can get to market quickly and scale successfully.


Qualio offers a scalable system for your team that is easy to implement and use

Our platform scales across teams and products as your company grows and, unlike paper or spreadsheets, is completely flexible.

Qualio is rated as the #1 “easiest setup” and “easiest to use” of all eQMS reviewed on G2. Our expert team ensures a quick implementation and our intuitive platform is loved by everyone from quality experts to basic users.


Have quality and regulatory
experts on your side

Add Qualio+ to your plan and receive expert quality assurance
support to help your business scale, mature and get to market.

Ready-to-go regulatory content

Access pre-configured templates and documentation for faster and smoother FDA & ISO compliance.


Quality assurance

Work with our team of seasoned quality experts to ensure you meet - and exceed - your QA goals.


Qualio is purpose-built for life sciences

We provide targeted software for the entire life sciences ecosystem.
Find out how we are the right fit for your company.

Medical Devices

Streamline your medical device product development while ensuring your teams stay compliant.



Embed industry-leading pharmaceutical quality processes that simplify and unlock FDA, ISO and ICH Q10 compliance.



Connect and centralize your document management, lab investigations, batch records, suppliers and more.



Earn regulatory trust and position your business for growth with a robust and quality-first approach.


Software as Medical Device

Unlock end-to-end control of your SaMD product lifecycle, from design controls to risk management.


Contract Research Orgs

Deliver a compliant and continuously improving CRO service, from R&D to clinical trials and post-market surveillance.


We do the heavy lifting - so you can
focus on what matters most

Qualio integrates with your business-critical applications to let you
automate cross-functional workflows, share data and build a
single source of truth for all your quality information.

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 the quality
management platform of choice