Clinical evidence remains one of the most challenging areas of medical device compliance. What do notified bodies expect? How can real-world and digital evidence strengthen your strategy? And why do so many CERs still fail?
During the Clinical & Performance Evidence track at the Medtech Compliance Forum by Aurevia & RAPS, experts will share practical insights on:
• ISO 18969 and evolving evidence expectations
• Real-world and digital evidence in device and IVD regulation
• Simulated clinical evidence and future applications
• Lessons learned from notified body assessments
• PMCF and PMPF strategies for software and AI devices
• Bridging regulatory requirements with clinical reality
Whether you're working in regulatory affairs, clinical development, quality, or product management, this track is designed to provide actionable knowledge you can bring back to your organization to stay ahead.
Explore the scientific programme
📍 Helsinki, Finland (Part of Labquality Days)
📅 11-12 February 2027