CE and UKCA marking with ease
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
CE and UKCA marking 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.
CE marking pathway guide
Access a step-by-step pathway guide for securing a UKCA mark.
UKCA marking pathway guide
Access a step-by-step pathway guide for securing a UKCA mark.
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