sitem-insel AG

M7 - Clinical Evaluation for Medical Devices

Module leader: Danielle Giroud, MD-CLINICALS SA

Date and Credits

Start: 01.09.2021

Duration: 7 Weeks


Module 7 concentrates on the clinical evaluation required to demonstrate the device’s intended purpose without exposing users and patients to unnecessary risk. The module covers the collection and reporting of pre- and post-market clinical data including safety reporting.