Countdown to February 2026: FDA’s New QMSR and ISO 13485 Alignment скачать в хорошем качестве

Countdown to February 2026: FDA’s New QMSR and ISO 13485 Alignment

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 with 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 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.