Regulatory & Compliance
UKCA vs CE marking in 2026: which do you need first?
If you’re developing a medical device in the UK at the moment, one of the first regulatory questions you’ll run into is whether to aim
August 17, 2026
If you’re developing a medical device in the UK at the moment, one of the first regulatory questions you’ll run into is whether to aim
First of all, congratulations. Winning an Innovate UK or NIHR i4i award is a real achievement, the success rates are low and the assessors will
A rugged autoinjector taken from initial concept through to EU MDR Article 117, with the technical documentation built as the design developed.
Proving a scan-to-device workflow for a custom-fit wearable support device, from proof of concept through initial prototypes to a defined regulatory route.
Concept development, several rounds of silicone prototypes, technical drawings and a mapped regulatory route for an early stage bladder care venture.
“Can you build us a prototype?” is probably the most common opening question we get, and about half the time a prototype isn’t actually what
Every medical device on the UK or EU market has a technical file behind it. It’s the evidence pack that shows your device does what