VDE
09.10.2025 Online Webinar

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

Kostenfreie Teilnahme / Free Participation
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Termin
Beginn: 09.10.2025 13:55 Uhr
Ende: 09.10.2025 15:15 Uhr
Veranstaltungs-Sprache
en-US
Veranstaltungsort

Online

Beschreibung

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!

Veranstalter

Digitale Transformation und Plattformen

Referenten

Dr. Thorsten Prinz, VDE (Offenbach/Main)

Thomas Doerge, BSI (Frankfurt/Main)

Kontakte
Ansprechpartnerin
Helena Däsch
VDE Health
Merianstraße 28
63069 Offenbach

Yv2v4r.Urv9tyQAuv.t53 Tel. +49 69 8306876

Weitere Ansprechpartner
VDE Health
Merianstraße 28
63069 Offenbach

3v95QAuv.t53

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