Transcription of Final Document: Software as a Medical Device (SaMD ...
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Final Document: Software as a Medical Device (SaMD ...
IMDRF/SaMD WG/N41 Final :2017 Final Document Title: Software as a Medical Device (SaMD): Clinical Evaluation Authoring Group: Software as a Medical Device Working Group Date: 21 September 2017 J. Patrick Stewart, IMDRF Chair This document was produced by the International Medical Device Regulators Forum. There are no restrictions on the reproduction or use of this document; however, incorporation of this document, in part or in whole, into another document, or its translation into languages other than English, does not convey or represent an endorsement of any kind by the International Medical Device Regulators Forum.
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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