Artificial Intelligence (AI) Algorithms as Medical Devices – Regulatory Requirements

This webinar will discuss the impact of incorporating Artificial Intelligence based algorithm on the premarket regulatory requirements from medical devices and healthcare products. The regulatory requirements associated with AI based software as medical device products will be mapped and the regulatory classification of AI based products in the US and the EU will be outlined.

This webinar aims to inform entrepreneurs, product architects, designers, developers, regulatory and quality professionals so that they can understand the regulatory expectations from AI based algorithm software as a medical device.

Areas Covered in the Session :

  • AI in healthcare – brief overview
  • The impact of AI based algorithms on medical device classification
  • Impact on pre-market regulatory requirements in the US and the EU
  • Clinical validation of AI based medical devices
Who Should Attend:

  • CEO’s, entrepreneurs of AI based algorithm software as medical devices that wish to understand the regulatory landscape.
  • Product managers and designers that wish to understand how the regulatory requirements shape their products requirements and development standards.
  • Quality and regulatory professionals that are responsible for regulatory compliance of AI based products.
  • Medical professionals and Clinical specialists that are engaged in the development and commercialization of AI based healthcare products.


Gadi Ginot

Gadi Ginot (M.Sc., MBA), CEO & Founder of Physio-Logic Ltd, Israel’s largest and leading provider of accelerated medical device approval, certification and regulatory compliance solutions ( Gadi is internationally renowned for mastering medical device registration, quality and clinical development and his track record extends over 25 years in three continents. Gadi streamlined the regulatory approval of over 100 medical devices leveraging his proficiency in regulatory sciences and his signature out of the box regulatory and clinical strategies. Gadi engineered the “Physio-Logic DNA” based on this formula.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance