Medical Device Clinical Investigations and ISO 14155
This UL white paper discusses the scope of clinical investigations applicable to medical devices, the role of ISO 14155, Clinical Investigation of Medical Devices for Human Subjects—Good Clinical Practice (GCP) in the acceptance of clinical data by regulatory authorities.
Beginning with an overview of the types of medical devices subject to clinical investigations, the paper next reviews some of the current challenges facing device manufacturers in conducting clinical investigations. Then, the white paper will present a brief history of ISO 14155 and the status of its acceptance by regulatory authorities around the world, before offering a detailed summary of the standard’s key provisions.
The paper concludes with some additional considerations for medical device manufacturers in designing clinical investigations that are aligned with regulatory requirements.