Clinical investigation of medical devices for human subjects - General requirements Ingestion-build-225643 Annex E (normative) Determination of
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Clinical investigation of medical devices for human subjects - General requirements Ingestion-build-225643 Annex E (normative) Determination ofClinical investigation of medical devices for human subjects Part 1: General requirements This part of ISO 14155 defines procedures for conducting and performing clinical investigations of medical devices. It specifies general requirements intended to: protect human subjects ensure the scientific conduct of the clinical investigation assist sponsors, monitors, investigators, ethics committees, regulatory authorities and bodies involved in the
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