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
“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