Regulatory & Compliance
Do you need ISO 13485 certification to UKCA or CE mark a device?
The short answer is no. There is no device class where the law says you must hold an ISO 13485 certificate before you can UKCA
November 2, 2026
The short answer is no. There is no device class where the law says you must hold an ISO 13485 certificate before you can UKCA
An ISO 13485 internal audit plan is a documented schedule setting out which parts of your quality management system will be audited, when, against what
If you search for a medical device technical file template you will mostly find tables of contents rather than anything you can actually use, so
When someone gets in touch with a device idea, one of the first things they usually want to know is what the path from idea
If you’ve got a medical device with some history behind it, perhaps a technical file written under the old directives or documentation inherited from a
Class I is the lowest risk class under the UK Medical Devices Regulations 2002, and it covers a surprising amount of ground, from walking aids
If you’re developing an autoinjector, a prefilled pen or an inhaler, most of the regulatory attention (and usually most of the budget) goes on the
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