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

  • Dec 3 2024
  • Durée: 28 min
  • Podcast

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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  • Résumé

  • 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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