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Beat Steffen Location
Düdingen, FR, CH
Beat Steffen Work
RAPS Board of Directors @ (January 2026 - Present)
Founder and Principal Consultant @ (October 2025 - Present)
Co-Founder, Chairman, Head of QM and RA @ (July 2016 - Present)
Lead Auditor @ (March 2006 - Present)
Lecturer @ (August 2020 - Present)
Special Coach Regulatory Affairs in Medtech and Biotech @ Innosuisse (April 2025 - Present)
Founder, Chairman and Principal Consultant @ (July 2023 - October 2025)
Founder, Chairman @ (September 2018 - July 2023)
Founder, Chairman and CEO @ (July 2005 - July 2023)
Head of Project and Risk Management @ (March 2002 - June 2005)
Senior Project Manager @ (January 1999 - February 2002)
Beat Steffen Skills
ISO 13485
Medical Devices
Quality System
Validation
ISO 14971
Regulatory Affairs
Design Control
V&V
Product Development
21 CFR Part 11
FDA
GMP
Quality Management
Computer System Validation
Continuous Improvement
Testing
Quality Assurance
CAPA
GAMP
Medical Device Directive
21 CFR
IEC 60601
Combination Products
21 CFR Part 4
Entrepreneurship
U.S. Title 21 CFR Part 11 Regulation
Pharmaceutics
Commercialization
Beat Steffen Summary
Beat Steffen, based in Düdingen, FR, CH, is currently a Founder and Principal Consultant at confinis. Beat Steffen brings experience from previous roles at Regulatory Affairs Professionals Society (RAPS), Medical Human Factors (medHF), SQS - Swiss Association for Quality and Management Systems and sitem-insel AG. With a robust skill set that includes ISO 13485, Medical Devices, Quality System, Validation, ISO 14971 and more. Beat Steffen has 4 emails and 1 mobile phone numbers on RocketReach.
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