The future of regulatory approvals for AI medical devices in the UK (and EU). With James Dewar- Co-founder of Scarlet
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The future of regulatory approvals for AI medical devices in the UK (and EU). With James Dewar- Co-founder of Scarlet
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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
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