FDA to Discuss Quality Management System Regulation (QMSR) – Risk and Design and Development
The U.S. Food and Drug Administration (FDA) is inviting industry professionals and stakeholders to participate in an upcoming town hall focused on the Quality Management System Regulation (QMSR). This session will provide valuable insights into how the QMSR addresses risk management, risk-based decision-making, and the design and development of medical devices.
During the event, FDA representatives will discuss key aspects of the QMSR and respond to frequently asked questions on risk and design, as well as development. The town hall aims to clarify the FDA’s expectations and help manufacturers better understand how to implement the regulation in alignment with international best practices.
The QMSR is harmonized with ISO 13485:2016, the globally recognized standard for medical device quality management systems. This alignment is intended to streamline regulatory requirements for manufacturers, promote international market access, and enhance consistency in medical device quality practices worldwide.
Event Details:
- Date: January 14, 2026
- Time: 2:00 – 3:00 p.m. ET
- Registration: Not required
All interested parties are encouraged to attend and take advantage of this opportunity to engage directly with FDA experts on these important topics.
Register Here.
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