Thursday, 15 October 2026 | 15:25 - 16:40
C1: Regulatory workflow transformation in notified bodies and companies: How to reduce complexity and boost efficiency
Location:Room 1: Maria Theresia
- 15:25: Peter Kramar: Artificial Intelligence in Regulatory Field: Current Practice, Challenges, and Future Directions
- 15:50: Batoul Belal: From Self-Certification to Notified Body Approval: Lessons from nyra health’s Class I MDD to Class IIa MDR Journey
- 16:15: Lukas Poterpin: Industry insights: Why manufacturers automate now, how they get started, and the impact on regulatory teams
3 speakers
Quality and Compliance Team Lead
nyra health
Department director for medical device certification
SIQ Ljubljana
Co-Initiator / Regulatory Affairs
Confideck GmbH