sitem-insel AG

Beat U. Steffen

Founder, Chairman & CEO of confinis ag, (Switzerland and USA)



Modules

Medical Device Regulatory Affairs and Quality Assurance:


Biography

Beat U. Steffen, Founder, Chairman & CEO of confinis ag, (Switzerland and USA) holds a MSc in electrical engineering an executive MBA and has 25+ years of experience in medical device and combination product development/manufacturing/quality management/regulatory affairs. He worked for Disetronic and Ypsomed and was responsible for a number of development projects from the first idea to successful registration and commercialization as well as infrastructure projects.

He founded confinis ag (www.confinis.com) in 2005. Besides providing professional services and advice to clients in the medical device, pharmaceutical and biotech field (with particular expertise and experience in combination products), he works as a freelance auditor with a focus on EN ISO 13485, Council Directive 93/42/EEC, MDSAP (Medical Device Single Audit Program) and MDR EU 2017/745 (designation pending) for SQS and DQS.

In addition to confinis, he co-founded Medical Human Factors AG (https://med-hf.ch/) in 2016, a company specialized in evaluating the use-related safety, effectiveness and usability of medical products and confinis CPM (www.confinis-cpm.com/) in 2018, a virtual workplace that provides senior-level clinical project staff and functional service professionals to gather clinical data.