AI Literacy for MedTech:

Regulatory Augmented Intelligence

Date: 5 September 2025

Time: 13:00–17:00

Location: Veembroederhof 96, Amsterdam

Exclusive access for only 25 participants

Registration Fee: €99 (excl. VAT)

Since February 2025, every deployer and provider of AI systems is legally required under the EU AI Act to be AI literate, that is, to understand the opportunities, risks, and responsible use of AI in their specific context. This goes beyond compliance checklists and requires a foundational understanding of how AI works, how to assess its impact, and how to deploy it responsibly.

For the MedTech sector, this obligation is even more complex due to the additional regulatory requirements of the MDR and IVDR.

This interactive seminar is designed to build AI literacy in the MedTech sector, with a strong focus on regulatory compliance, legal context, and practical application. Experts from industry, law, and AI development will walk you through the opportunities and risks of using AI in medical devices, in light of the EU AI Act and existing MDR/IVDR frameworks.

Whether you’re just starting or already working with AI systems, you’ll gain practical insights and learn from real cases and tools in use today.

What to expect

  • AI literacy explained

  • The AI Act and its implications for MedTech

  • Compliance strategies: interplay between AI, MDR, and IVDR

  • Insights from a Notified Body

  • Fairness, bias, and the future of AI

  • Real-life use of tools like ChatMDR & ChatIVDR

  • Behind the scenes of a dedicated AI tool for Regulatory Affairs

  • Panel discussion on AI Act implementation and Practical use of AI tools

  • Networking drinks with demos and informal Q&A

Speakers

  • Partner at Axon Lawyers

  • Attorney-at-law at Axon Lawyers

  • Director Governmental Affairs EU at Elekta

  • Senior Director, Global Head of Regulatory Afairs, and IGT Systems at Philips

  • Associate Head AI Notified Body at BSI

  • Co-creator of ChatMDR / ChatIVDR

  • Founder and Senior Regulatory Consultant at CREATE 

Registration Form – AI Literacy for MedTech Seminar