Full Name
Mr. André Breisinger
Job Title
Medical Devices Regulation Expert
Company
Swissmedic
Speaker Bio
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 MD 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 as an official observer 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).
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).
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