Town Hall – Quality Management System Regulation: Risk and Design and Development January 14, 2026

https://www.fda.gov/medical-devices/medical-devices-news-and-events/town-hall-quality-management-system-regulation-risk-and-design-and-development-01142026?utm_medium=email&utm_source=govdelivery Town Hall – Quality Management System Regulation: Risk and Design and Development The U.S. Food and Drug Administration (FDA) will host a town hall for industry and other interested parties on the Quality Management System Regulation (QMSR). The FDA will discuss how the QMSR addresses risk management, risk-based approach, risk-based decisions, and design and development and will address frequently asked questions regarding these topics. The QMSR aligns with the internationally recognized ISO 13485:2016 standard for medical device quality management systems and is intended to reduce regulatory burdens for manufacturers, facilitate global market access, and improve consistency of medical device quality practices. Dates: January 14, 2026 Time: 2:00 – 3:00 p.m. ET Registration is not required.