Saskia Dunkel-de Raad

Dr Saskia Dunkel-de Raad

Associate Director

Dr Saskia Dunkel-de Raad is a biochemist by education with 17+ years of experience in clinical studies of MDs and MPs from multiple perspectives: CRO, global sponsor, investigator and Swiss Competent Authorities. At Swissmedic, Saskia assessed and authorized/denied new applications and amendments of pre-market MD studies. In addition, she was responsible for the safety of study subjects in ongoing clinical studies and conducted routine and for cause inspections at investigators and sponsors. Saskia is an expert in the qualification and classification of products and accordingly was a Swiss member of the European Commission Borderline and Classification Expert Group. She also has deep experience in the request of humanitarian exemptions. Within Medidee, Saskia is overseeing all activities related to clinical studies, their quality and their regulatory and ethical compliance (ISO 14155 and GCP).
Saskia speaks French, English and German.


Gaëlle Diserens - Medide Services

Dr Gaëlle Diserens

Senior Associate

Dr. Gaëlle Diserens works as Clinical, Quality & Regulatory Affairs Consultant, providing services to manufacturers of Medical Devices and In-vitro Diagnostic Devices. Her expertise covers, among others, clinical evaluations, clinical investigations, clinical strategy, technical documentation preparation for CE marking, risk analysis, and strategic planning for regulatory pathways. Gaëlle holds a PhD in biomedical sciences from the University of Bern. She has seven years of experience as research scientist in different academic and industries in Switzerland and in England. Her expertise in clinical affairs and medical imaging was developed during her PhD and post-doctoral positions, when she was working in a clinical environment.
Gaëlle is fluent in French, English and German.