C1: Cybersecurity and IT security

15:15-15:40 Larissa Naber: The Connected Medical Device and Its Natural Enemies

Medical device connectivity isn’t a feature — it’s a battlefield. This talk explores the natural enemies of connected medical devices: hackers, misconceptions, regulatory pitfalls, and sometimes even the devices’ users. Join me to learn how to separate security fact from fiction, how to detect snake oil and how the FDA cybersecurity guidance can help even if you don’t plan to go to the US market.

15:40-16:05 Aljaz Podborsek: Cybersecurity of Software in Healthcare and Medical Devices - the Role of the IEC 81001-5-1 Standard

Cybersecurity is essential for ensuring the safety and performance of medical devices and health software. This talk will explore how the IEC 81001-5-1 standard defines security activities throughout the software lifecycle. It will highlight key challenges and considerations for manufacturers and regulators alike.

16:05-16:30 Nilaykumar Patel: Cybersecurity for SaMD: Cybersecurity-related Documentation in Technical File Preparation for Review by Notified Body.

During the session, I plan to share insights on the essential cybersecurity documentation that medical device manufacturers need to compile to demonstrate compliance. This will cover preparing a technical file for initial applications and navigating routine reviews by the notified body.