Founder, Chairman of the Board of Directors & CEO
confinis ag, Switzerland
Founder, Chairman of the Board of Directors & CEO of confinis ag, (Switzerland, USA, UK) holds an MSc in electrical engineering and an Executive MBA and has more than 20 years of experience in the development, manufacture, quality management / 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 registration and commercialization as well as for infrastructure projects.
In 2005 he founded confinis ag. In addition to providing professional services and advice for customers in the field of Medical Device, Pharma and Biotech (with special expertise and experience in the field of combination products, he works as a freelance auditor with a focus on EN ISO 13485, MDSAP (Medical Device Single Audit Program) and MDR EU 2017/745 (designation pending) for SQS and DQS. He is also a lecturer for design control at the Bern University of Applied Sciences and for MDR and combination products at the University of Berne (MAS in Medical Device Regulatory Affairs and Quality Management).
In addition to confinis, he co-founded Medical Human Factors AG in 2016, a company that specializes in assessing the application-related safety, efficacy and usability of medical products, and in 2018 confinis CPM, a virtual workplace where leading clinical professionals - Project staff and specialists are available for functional clinical data services.
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Thursday, May 11, 2023
13:45 – 14:45 CEST