sitem-insel AG

Beat U. Steffen

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


Medical Device Regulatory Affairs and Quality Assurance:


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 ( 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 ( in 2016, a company specialized in evaluating the use-related safety, effectiveness and usability of medical products and confinis CPM ( in 2018, a virtual workplace that provides senior-level clinical project staff and functional service professionals to gather clinical data.