Masterclass: Artificial Intelligence-based Medical Devices

In this course, we’ll explore global legislative trends, providing an overview of current and proposed legislation and standards applicable to AI-based medical devices while taking lessons learnt from regulatory submissions of AI-based medical devices.

The European AI Act, soon to be upon us, will redefine specific medical devices as ‘high-risk AI systems’, ensuring they are legal, ethical, safe, and robust. Our course leader will demystify this Act, revealing its intricate interplay with existing medical device regulations, empowering manufacturers to secure their portfolios and gain a competitive edge. As you conclude this session, you’ll emerge enlightened about the AI Act’s profound impact on the medical device industry, its areas of consensus and ongoing debates.

As data is the lifeblood of AI-based medical devices we’ll immerse you in contemporary data management and governance practices, aligning with standards and the proposed European Data Act and European Health Data Space.

Lastly, we’ll explore adaptive AI-based medical devices, which dynamically adapt to clinical settings or individual patients. Discover their market presence, compliance with regulations, and strategies to earn trust with authorities.

This course offers a factual and comprehensive exploration of the evolving landscape of AI-based medical devices and the regulatory frameworks that govern them.