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Beat U. Steffen

Leader background:
Beat U. Steffen holds an MSc in electrical engineering, an Executive MBA and has 20+ years experience in the development, registration, and lifecycle management of medical devices and combination products. In 2005, Beat founded confinis, a global regulatory consulting firm based in Switzerland and the US. During this time, he has played a key role in obtaining marketing authorization for many combination products in the EU and the US. Beat is also a lead auditor regarding ISO 13485, MDD/MDR, and MDSAP for a Notified Body. In 2016, he co-founded Medical Human Factors (medHF), a company specialised in evaluating the use, related safety, effectiveness, and usability of medical products. In 2018, he founded confinis CPM, a virtual workplace which provides clients with senior level clinical project staff and functional service professionals to gather clinical data to sell their medical devices. Beat is co-author of the “Combination Products” chapter of Fundamentals of International Regulatory Affairs, Fourth Edition (RAPS) and is an expert representing Switzerland in ISO TC 84 regarding needle-based injection systems.
Drug-device combination products: regulations and documentations
    Level: Area: Expert Seminar Series
    Code: ESS31.1 Duration: 00:45:00