Jumpstart Your QMSR Transition: Get Ahead Of Evolving Regulations

The FDA has implemented the Quality Management System Regulation (QMSR) as a successor to the existing Quality System Regulation (QSR) for medical devices. This reform signifies the FDA's commitment to aligning with the international standard ISO 13485:2016 and emphasizing a risk-based approach to quality management. The QMSR is expected to enhance the consistency, efficiency, and effectiveness of the FDA's oversight and inspection of medical device manufacturers. This transition will have significant implications for the medical device industry, as it will necessitate changes in the processes followed to bring medical devices and device-led combination products to the US market.

In this webinar, join Kymanox experts in Quality and Regulatory Affairs as they guide you through your transition to the QMSR, discussing key changes and impact from new requirements, ensuring that your company achieves compliance by the February 2026 effective date.