This webinar will discuss the impact of incorporating AI on the premarket regulatory requirements from medical devices and healthcare products. The additional evidence that is needed to get AI based products to the healthcare market 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 what the regulatory expectations are from AI based medical devices and healthcare products.
Areas Covered in the Session :
- AI in healthcare – brief overview
- The impact of AI 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, entrepreneurs of AI based healthcare tool 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
Course Director: 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 (www.physio-logic.co.il). 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.