Good Clinical Practice (GCP) for Medical Device Clinical Investigations -- ISO 14155:2020

In this booklet, you will find requirements described in the ISO 14155:2020. The ISO 14155:2020 defines requirements to protect the rights, safety and well-being of human subjects; to ensure that the results of a clinical trial are credible; to confirm the scientific conduct of the clinical study; and to specify the responsibilities of the ethics committees, regulatory authorities and other bodies involved in the clinical trial as well as the responsibilities of the sponsor and the investigators. Compliance with ISO 14155:2020 is an essential contribution to the overall trial success.