Date: 9 October 2024
Location: Abbott - Conway Park, Illinois, United States
Language: English
Introduction
The session will provide an understanding of the general principles of the EU AI Act and its regulatory and quality consequences, with a special focus on medical devices and health software. We will explore the Act's risk classification system, ranging from minimal risk to high risk, and learn how different AI applications are regulated based on their potential impact. We’ll provide some first insights into the specific requirements for high-risk AI systems (basically including most medical devices and IVDs), including data governance, transparency, human oversight, and robustness. In addition, we will talk about the roles and responsibilities of different stakeholders, including providers, deployers, authorized representatives, importers and distributors, in ensuring compliance with the EU AI Act.
Join Gert Bos and Sue Spencer for sessions discussing a selection of the potential challenges and opportunities the Act presents for innovation in the AI and medical device sectors.
For more information about the event, visit the RAPS event website.
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