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Learning Level: Foundational
Learning Level: Foundational
Learning Level: Intermediate
Learning Level: Intermediate
Learning Level: Advanced
Learning Level: Advanced
Learning Level: Expert
Learning Level: Expert
Networking Event
Networking Event
Sponsor Presentation
Sponsor Presentation
Ticketed Event
Ticketed Event

Beat U. Steffen, MSc, RAC, FRAPS (he/him/his)

Founder, Chairman of the Board of Directors & CEO
confinis ag
Duedingen, Fribourg, Switzerland

Founder, Chairman & Principal Consultant of confinis ag. Holds a MSc in electrical engineering and an Executive MBA and has 30 years of experience in the development, manufacture, quality management and regulatory affairs of medical devices and combination products. He worked for Disetronic and Ypsomed and was responsible for a number of development projects from the first idea to successful market authorization and commercialization.
In 2005 he founded confinis. In addition to providing professional services and advice for clients in the field of Medical Devices, Pharmaceuticals and Biopharmaceuticals (with particular expertise and experience in the field of drug-device combination products), he works as a freelance lead auditor with a focus on ISO 13485, MDSAP (Medical Device Single Audit Program), ISO 15378, and MDR for SQS and DQS. He is also a lecturer for combination products and MDR at the University of Bern (MAS in Medical Device Regulatory Affairs and Quality Management) and design control at the Bern University of Applied Sciences.
For RAPS he co-authored the chapters regarding Combination Products in the publications Fundamentals of International Regulatory Affairs, Fundamentals of Pharmaceutical and Biologics Regulations: A Global Perspective, and Fundamentals of Medical Device Regulations: A Global Perspective.
In 2021 he was honored as a RAPS Fellow (FRAPS) and in 2023 he obtained the RAC Device Regulatory Affairs Certification from RAPS.
In addition to confinis, he co-founded Medical Human Factors AG (medHF) in 2016, a company that specializes in assessing the application-related safety, efficacy and usability of medical products.

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