DiscoverDigital Health Section Podcast- Royal Society of MedicineThe future of regulatory approvals for AI medical devices in the UK (and EU). With James Dewar- Co-founder of Scarlet
The future of regulatory approvals for AI medical devices in the UK (and EU). With James Dewar- Co-founder of Scarlet

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

Update: 2024-12-03
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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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The future of regulatory approvals for AI medical devices in the UK (and EU). With James Dewar- Co-founder of Scarlet

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

RSM Digital Health Council