Description

The Investigator Brochure Template, in alignment with ISO 14155, offers a standardized format for compiling essential information required for conducting clinical investigations of medical devices. This template serves as a comprehensive document detailing the background, objectives, methodology, and safety information related to the investigational device. It includes sections covering device description, preclinical data, clinical study protocol, adverse event reporting procedures, and investigator responsibilities. By utilizing the Investigator Brochure Template, sponsors and investigators can ensure consistent and thorough communication of critical information throughout the clinical investigation process.