FDA QMSR alignment with ISO 13485 – practical implications for medical devices and combination products

In 2022, the FDA published a proposed rule to align the U.S. medical device quality regulation with international standards  ISO 13486:2016. The presentation with provide a quick overview of the historical situation and the practical implications for medical device and combination product design and development of the FDA’s final rule on QMSR, including the timeline for its implementation. The implications that will be discussed include terminology changes, impact on design control documentation, and change control, risk management, and CAPA processes.