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