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ANSI/AAMI/ISO 14155:2020
Clinical investigation of medical devices for human subjects - Good clinical practice
This document addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices. For post-market clinical investigations, the principles set forth in this document can be followed as far as relevant, considering the nature of the clinical investigation (see Annex I).
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Association for the Advancement of Medical Instrumentation [aami]
