Webinar – Navigating the shifting regulatory landscape: EU MDR/IVDR, FDA QMSR, and what it means for your QMS- BioVia

The regulatory landscape for medical devices is evolving rapidly on both sides of the Atlantic—and staying ahead is critical.

Join Biovia’s upcoming webinar on May 7^th 2026 from 10-11:15CET time to unpack the latest updates to EU MDR/IVDR and the new FDA QMSR, including what they mean for your quality management systems, submissions, and audit readiness. You’ll also gain insights into rising FDA expectations around AI, cybersecurity, and submission quality.

🎯 What you’ll learn:
• Key regulatory changes and their drivers
• How AI and cybersecurity are reshaping requirements
• Common FDA submission pitfalls—and how to avoid them
• Practical steps to translate regulations into QMS action
Featuring expert perspectives from Sophie Smolders, PhD (StingOrg Group), Ruth Beckers (Qualix), and Mieke Janssen(pRA Consulting), moderated by Sandra van Londen (HQ Vector)
If you haven’t subscribed yet, there are still a few free spots available—for both members and non-members.