Digital Health Section Podcast- Royal Society of Medicine

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

  • ...more
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    Digital Health Section Podcast- Royal Society of MedicineBy RSM Digital Health Council


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