Published On:
February 14, 2024
On 02 FEB 2024, FDA issued the Quality Management System Regulation (QMSR) final rule to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation to harmonize and modernize the regulation. This paper provides a summary of the new QMSR rule, outlines its key revisions, and offers recommendations for device manufacturers to assess, enhance, and ensure compliance of their quality system.
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