Artificial Intelligence (AI) is a topic on everybody's mind – manufacturers are increasingly using AI tooling as part of the development process, as well as AI algorithms in their medical devices. Yet, at the same time, cyber-adversaries are using AI to find new vulnerabilities and orchestrate attacks while we are using AI in cyber-defense and to support cyber-maintenance.

This session will provide an overview of how AI will shape the future of medical devices and what manufacturers and users need to understand in order to benefit from this new technology without risking its pitfalls. We will cover the basics of AI-tooling, AI use in products, evolving AI regulation, and AI in cybersecurity. Attendees will understand the breadth and challenges associated with AI and its intended and unintended consequences.

Hosted by: Johner Institut, Medcrypt, MedISAO

In this session, you'll learn:

1. The basics of AI tooling and how manufacturers are weaving it into the development process
2. How AI algorithms are increasingly built directly into medical devices
3. How adversaries are using AI to find vulnerabilities and orchestrate attacks
4. How defenders are using AI for cyber-defense and cyber-maintenance
5. How AI regulation is evolving — FDA guidance, the EU AI Act, and MDR (MDCG 2025-6)
6. The intended and unintended consequences manufacturers and users need to plan for

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