On February 23, 2022, the FDA published the long-awaited proposed rule to align U.S. medical device quality regulations with international standards. This session will discuss the notable changes in the proposed Quality Management System Regulation, the most current expectations regarding how and when the rule will be finalized and implemented, and how it will impact both industry and the FDA itself. Even firms already certified to ISO 13485:2016 will have to adjust their quality systems, so don’t miss this critical update.