9/27/2023 0 Comments Iso 13485 auditThe terms "Exclusion" & "Non-applicability" have been reinforced.The text, "Control over Audits performed by CMDCAS recognized registrars" has been removed.Under the document's Purpose, a paragraph has been added to describe how medical device manufacturers can use the document.References to ISO 13485:2003 have been added and references to 13485:1996/8 have been removed.
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