QUALITY MANAGEMENT APPLICATIONS AND REGULATORY COMPLIANCE
Language: English
Bureau Veritas organizes a new webinar focused on how Artificial Intelligence is transforming the way organizations manage quality, compliance, and efficiency.
During this session, we will explore how AI can strengthen Quality Management Systems (QMS) by improving efficiency, reducing manual workload, ensuring compliance, and enabling predictive insights. Participants will discover elements of the ISO/IEC 42001 and the EU AI Act and gain practical insights from real-world case studies and validation strategies.
This webinar will provides essential guidance from a Notified Body perspective (NB 1370) exploring the intersection of artificial intelligence and medical device regulation. We'll examine the EU AI Act's impact on medical devices, including the new MDCG 2025-6 guidance on the interplay between MDR/IVDR and AIA requirements.
AGENDA
- Introduction to Bureau Veritas Switzerland & KAHLITY collaboration
- AI in Quality Management System
- AI applications and Validation of the AI solution
- From insights to action
- Medical Device and Artificial Intelligence Systems: a Notified Body perspective
- Key Takeaways & Q&A.
SPEAKERS
Alessio Quaranta, Medical Device Product Development Leader - Bureau Veritas
Mélodie Kahl, Lead Auditor, Trainer and Owner of KAHLITY GmbH