In this episode focusses on the future of regulatory approvals for AI software medical devices in the UK (and EU).

Featuring guest James Dewar- Co-founder of Scarlet a EU Notified body and UK approved body that specialises in certifying software medical devices.

Key discussion topics:

The current regulatory position of the UK post-Brexit and the opportunities that this could present
The practical impact of the EU AI act for medical device manufacturers within the EU.
What makes regulatory submissions uniquely challenging for AI devices
Getting novel technologies such as Large Language model and other foundation models regulatory approval

Episode 297: A Near Death Experience