Investigator's Brochure

Fraunhofer AICOS can write up the Investigator’s Brochure of your medical device, ensuring you will have a document with all the clinical and pre-clinical data about your medical device that is relevant for the clinical studies with humans and in compliance 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.