Regulatory & Compliance
ISO 13485 internal audit: how to prepare
Internal audits are one of those QMS activities that tend to get left until the certification body visit is looming, at which point they get
September 14, 2026
Internal audits are one of those QMS activities that tend to get left until the certification body visit is looming, at which point they get
Quite a bit of the work we do at MDIN starts with someone who has a device idea, often a clinician or a small company
There comes a point in most device projects where opinions have to give way to measurements. You can model a part, review it and debate
When someone gets in touch about prototyping a device, the first two questions are nearly always what it will cost and how long it will
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