Lea Wettlaufer has been writing clinical evaluations and developing clinical strategies for marketing authorization and post market surveillance of medical devices at the Johner Institute since 2017. Ms. Wettlaufer is responsible for supporting medical device manufacturers in the scope of the MDR on all topics related to clinical data, the clinical development plan, clinical evaluations, and clinical follow-up. She is a trainer for topics according to clinical data under MDR and is speaker at our Medical Device Days and lecturer for the study curse “regulatory affairs”. She is responsible for the development of seminars and workshops. Lea Wettlaufer has extensive insight into clinical research through her training as a Clinical Research Associate.