André Breisinger

Expert Medical Devices Regulation at Swissmedic

Speaker

André Breisinger is with Swissmedic, the Swiss Agency for Therapeutic Products in the Medical Devices surveillance sector. He predominantly works on implementation projects, most of which are related to the Swiss medical device and IVD regulation. In his interface role, he acts, among other things, as the single point of contact for the Medtech Roundtable with national stakeholders and represents Swissmedic in the Management Committee of the IMDRF.

Mr. Breisinger holds a federal diploma in Business Administration and has a further education in quality and process management. Mr. Breisinger has been working in the area of medical devices since 2009. He gathered extensive regulatory affairs experience working for a notified body and for legal manufacturers. He was leading or contributing to projects in the area of quality management, product development, packaging and labelling, requirements management, regulatory submissions and UDI (serialisation with data matrix, labelling and UDI databases).