The FDA proposes to do so primarily by incorporating by reference the 2016 edition of the international standard specific for medical device quality management systems set by the International Organization for Standardization (ISO), ISO 13485. On February 23, 2022, the FDA issued a proposed rule to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation to align more closely with the international consensus standard for Quality Management Systems for medical devices used by many other regulatory authorities around the world.
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