Wednesday, 15 October 2025 | 15:15 - 16:30
C1: Cybersecurity and IT security
- Tina Vodopivec: Cybersecurity of Software in Healthcare and Medical Devices - the Role of the IEC 81001-5-1 Standard
- Nilaykumar Patel: Cybersecurity for SaMD: Cybersecurity-related Documentation in Technical File Preparation for Review by Notified Body
- Larissa Naber: The Connected Medical Device and Its Natural Enemies
15:15-15:35 Larissa Naber: The Connected Medical Device and Its Natural Enemies
15:40-16:00 Tina Vodopivec: 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.
16:05-16:25 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.
3 speakers
SIQ Ljubljana