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.
- 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
- 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.