Alerts3.15.22
FDA Proposes to Harmonize Medical Device Quality System Regulations With ISO 13485
The FDA has published a proposed rule to align its medical device quality system regulations with the ISO 13485 quality system
The Food and Drug Administration (FDA) published a proposed rule in the Federal Register “proposing to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation to align more closely with… the 2016 edition of ISO 13485.”
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