Clinical investigation of medical devices for human subjects - General requirements shop-only upgrade paths

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Clinical investigation of medical devices for human subjects - General requirements shop-only upgrade pathsBS EN ISO 14155 1: 2009 Clinical investigation of medical devices for human subjects. General requirements The standard defines the procedures for the conduct and performance of clinical investigations of medical devices, where their clinical performance and safety is being assessed in people. It is intended to protect people and to ensure the scientific conduct of the clinical investigation. BS EN ISO 14155 1 specifies requirements for the