Reg Talk Medical Engineering: Compliance-by-Design of AI-based medical devices (Online)

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The organizer is the VDE Verband der Elektrotechnik Elektronik Informationstechnik e.V (hereafter reffered to as VDE e.V.).

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Description

The EU medical device market is highly regulated by sector-specific (e.g. the EU Medical Device Regulation) and cross-sector (e.g. the EU AI Act) legislation. As a result, manufacturers need to invest significant human and time resources in regulatory compliance before placing their products on the EU market. This problem can be solved by adopting a 'compliance by design' approach, which integrates regulatory requirements into the medical device design and development process from the outset. In addition to cost efficiency, key benefits include faster time-to-market, improved product quality and regulatory flexibility.

In this event, the first presentation will deal with the most important legal and regulatory requirements for AI-based medical devices. As a solution, new processes and the adaptation of existing processes in the manufacturer's QMS will be presented, and finally, essential steps for a successful AI compliance project will be discussed.

The second presentation focuses on the Notified Body perspective. Both common pitfalls in CE conformity assessment as well as procedures, challenges and timelines under the AI Act will be highlighted.

We look forward to your participation!

Agenda

13:55	Welcome Zoe Narten, VDE
14:00	How to apply the Compliance-by-Design for AI-based medical device Thorsten Prinz, VDE Overview of legal and regulatory requirements Essential new processes and adaptation of existing processes in the manufacturer’s QMS Steps towards a successful AI Act compliance project
14:30	Fusion of AI and Medical Device Software from a Notified Body perspective Thomas Doerge, BSI Common pitfalls in the technical documentation and quality management processes for AI-based medical device Conformity assessment under the AI Act: procedure, challenges, and schedule
15:00	Summary and discussion
15:15	End of event

Preliminary program. Subject to changes / adjustments

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The event is organized for at least 10 participants. If the minimum number of participants is not reached one week before the start of the event, we reserve the right to cancel it. For organizational reasons, registration for our events usually closes 3 days before the event date. Thank you for your understanding.