Beat U. Steffen Confinis AG

Beat holds an MSc in electrical engineering, an Executive MBA and has 20+ years of 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 Düdingen (Switzerland) and North Potomac, MD (USA). During this time, he has played a key role in obtaining marketing authorization for many combination products that were approved in the EU and the US, both for originator and generic/biosimilar drugs/biologics. Beat is also a lead auditor regarding ISO 13485, Directive 93/42/EEC and MDSAP (Medical Device Single Audit Program) for a Swiss Notified Body and a German Certification Body. In 2016, he co-founded Medical Human Factors (medHF), a company specialized in evaluating the use related safety, effectiveness and usability of medical products based in Lucerne (Switzerland), Hamburg (Germany) and London (UK).

Prior to 2005, he worked for Disetronic and Ypsomed where he was responsible for a number of development projects for both small and large pharma/ biotech companies, which ranged from conception to successful registration and commercialization.

Beat is also a 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.