QHS016

Design, conduct, recording, and reporting of clinical investigations of medical devices for human subjects.

ISO 14155:2020 is a standard for the design, conduct, recording, and reporting of clinical investigations of medical devices for human subjects. The standard is published by the International Organization for Standardization (ISO) and applies to both pre and post market investigations. The 2020 version of the standard emphasizes the role of clinical evidence as presented in the Medical Device Regulation (MDR). It also provides clarification on the applicability of GCP to different clinical development stages. The standard has the following principles: Protect the rights, safety, and well-being of human subjects Ensure scientific conduct of the clinical investigation and credibility of the clinical investigation results Define the responsibilities of the sponsor and principal investigator The standard defines a clinical investigation as any systematic investigation involving one or more human subjects, undertaken to assess the clinical performance, effectiveness or safety of a medical device