On-demand webinar
Duration: 60 minutes
Beginning February 2, 2026, all manufacturers seeking to market devices in the United States must comply with the FDA’s new Quality Management System Regulation (QMSR). This regulation replaces the longstanding Quality System Regulation (QSR) and incorporates ISO 13485:2016 by reference, creating stronger alignment with international quality management requirements.
With QMSR’s alignment to ISO 13485:2016, manufacturers participating in the Medical Device Single Audit Program (MDSAP) will be well-positioned, as MDSAP audits are based on ISO 13485 and can support compliance across multiple markets, including the U.S.
In this on-demand webinar, hosted by TÜV SÜD, our experts will provide an overview of the regulation, highlight the changes compared to the former QSR, and outline how manufacturers can prepare their QMS for this transition.
We'll discuss:
- Transition from QSR to QMSR: scope and changes
- FDA’s incorporation of ISO 13485:2016 by reference
- February 2026 compliance deadline – what manufacturers must prepare
- The relationship between QMSR and MDSAP audits
- Lessons learned from ISO 13485 implementation globally
- The relationship between QMSR and MDSAP audits
- Lessons learned from ISO 13485 implementation globally
Join us live to gain a clear understanding of the new QMSR requirements and what steps your organization should prioritize ahead of the deadline.
Disclaimer:
This webinar is intended for general educational purposes only and does not provide product-specific guidance or regulatory guidance services. TÜV SÜD supports medical device manufacturers with accredited testing, certification, and auditing services to help demonstrate compliance with applicable requirements. Contact us to learn more.
