Get your device to market
on both sides of the Channel
Challenge
Medical device and in vitro medical device companies need to prove their products are safe and compliant to secure their CE and UKCA conformity marks.
But complex, shifting legislation and the impact of Brexit have made cracking the EU and UK markets a tricky task.
Manual quality, siloed processes and murky visibility make lasting compliance an onerous, time-consuming and energy-sapping burden.
Solution
Qualio's fully integrated eQMS software arms medical device companies with the tools they need for confident, long-term adherence to EU MDR/IVDR and UK MDR requirements.
Digital workflows, cloud-based documents and a single source of truth make it easy to connect your workforce to a collaborative quality culture.
CE and UKCA marks become a natural byproduct, not a stressful target.
How it works
EU MDR/IVDR (CE marking)
- Integrated medical device eQMS provides a ready-made structure for compliance, from design controls and management responsibility to clinical evaluation and UDI
- Meet every single annex requirement by aligning your teams around version-controlled documents, training records, workflow-driven digital processes and more
- Make your Notified Body auditor happy with instant access to centralized, audit-trailed and inspection-ready quality data
UK MHRA (UKCA marking)
- Assemble all the elements of a holistic medical device QMS, from design controls to training, in a single cloud-based system
- Control all aspects of your device's lifecycle, from design to PMS, and prove compliance to your Approved Body auditor
- Pinpoint risks and drive digital workflows for a connected, right-first-time and patient-centric approach
EU/UK medical device resources
EU MDR software datasheet
Dive deeper into how our software empowers your business for lasting EU market presence.
EU IVDR software datasheet
Bringing an IVDR to the EU market?
See how Qualio gives you everything you need.
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
"I joined in November. I contacted Qualio 2 weeks later. We went live mid-December. We had all users working in the system by January. And we had our ISO 13485 certification by July.
Without Qualio, we'd never have done that."
Karen H.
Head of Quality & GxP Compliance, 30 Technology
"We’ve been able to show certain clients what we’ve accomplished with Qualio, and they were very impressed.
The VP of Quality for a client company said, "If I could build from the bottom up, I’d do it exactly the way you guys did it"."
Stephana P.
VP of Quality, Alphazyme
"There are other eQMS providers that are very well-established, but not particularly accessible to organizations that don't have the fundamental basics in place.
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 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 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
"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
"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 support Kelly and the team gave us at the beginning was great and we were really leveraging them to build out our QMS from scratch.
It was so streamlined, it was so efficient, they were super helpful and communicative.
That's exactly what we needed - and that's why we went with Qualio.
Heather U.
CEO, EvoEndo