Investigator's Brochure training

Fraunhofer AICOS can provide your team with training on preparing the Investigator’s Brochure of medical devices, compliant with the International Standard ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice requirements. The Investigator's Brochure is an essential and mandatory document in the submission and approval of clinical studies with medical devices, and part of the information contained therein is also part of the technical documentation necessary for certification applications. We will guide you on how to write up the Investigator’s Brochure, by presenting its elements and structure, namely, the summary of the literature and evaluation, the device risk class classification, the intended indication for use, the device description, manufacturing and validation processes, and instructions for use and labelling.