Search results with tag "Ghtf sg5"

Final Document: Software as a Medical Device (SaMD ...

GHTF SG5 N2R8:2007 [8]. Clinical Evaluation see GHTF SG5 N2R8:2007 [8] 5.2 Valid Clinical Association of a SaMD For purposes of this document, valid clinical association, also known as scientific validity, is used to refer to the extent to which the SaMD’s output (concept, conclusion, measurements) is clinically accepted or well-founded

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