Navigating the shifting regulatory landscape: EU MDR/IVDR, FDA QMSR, and what it means for your QMS
The regulatory framework for medical devices is undergoing significant transformation on both sides of the Atlantic. The EU MDR and IVDR are being revised to address the risk of supply shortages and ensure continued patient access to critical devices, while simplifying requirements without compromising safety. At the same time, the FDA’s new Quality Management System Regulation (QMSR) incorporates ISO 13485:2016 by reference, a significant step toward harmonising the US regulatory framework with international standards.
Meanwhile, evolving FDA expectations around AI, cybersecurity, and submission quality are raising the bar for manufacturers seeking market access. This webinar brings together three expert perspectives to help MedTech companies understand what is changing, what is driving these changes, and how to translate new regulatory requirements into practical action for their quality management systems and submission strategies.
Session objectives
- Understand the key changes proposed under EU MDR/IVDR and the new FDA QMSR, and the rationale behind them
- Learn how evolving FDA expectations around AI and cybersecurity are reshaping documentation and validation requirements
- Identify common pitfalls in FDA submissions and how to avoid them
- Translate regulatory changes into concrete implications for your QMS, including audit and inspection readiness
Speakers
- Sophie Smolders, StingOrg
- Ruth Beckers, Qualix
- Mieke Janssen, pRA Consulting
- Moderated and hosted by Sandra Van Londen, HQ Vector
Session outline
- Welcome and introduction
- Presentation 1: EU MDR/IVDR and US FDA QMSR: Background, rationale and key changes, Ruth Beckers, Qualix (15min)
- Presentation 2: Regulatory changes at the FDA — why good submissions still trigger difficult questions, Mieke Janssen, Pra Consulting (15 min)
- Presentation 3: From regulation to reality, what these changes mean for your QMS and audit readiness, Sophie Smolders, StingOrg (15 min)
- Moderated panel discussion and Q&A (20 min)