Swiss Institute for Translational and Entrepreneurial Medicine (sitem-insel)

Module 4 - EU Medical Device Regulations Part C

Dr. Andrea Biasiucci

Competence Cluster Lead & Senior Consultant, confinis ag

Modules

Medical Device Regulatory Affairs and Quality Assurance

Module 4 - EU Medical Device Regulations Part C

Biography

Dr. Andrea Biasiucci is an Electronic and Biomedical engineer with a PhD in Brain-Machine Interfaces from the Swiss Federal Institute of Technology Lausanne (EPFL) and more than 10 years of experience in medical device innovation and digital health. At confinis, he leads the Competence Cluster in Clinical Evaluation, Active Implantable Medical Devices and Digital Health.

In addition, Andrea has extensive experience in clinical affairs related to EU registrations, post-market surveillance and post-market clinical follow-up, including AI and Machine Learning projects.