2016 -now Co-Founder, Chairman, Head of QM and RA @
2006 -now Lead Auditor @
2020 -now Lecturer @
2025 -now Special Coach Regulatory Affairs in Medtech and Biotech @ Innosuisse
2023 -2025 Founder, Chairman and Principal Consultant @
2018 -2023 Founder, Chairman @
2005 -2023 Founder, Chairman and CEO @
2002 -2005 Head of Project and Risk Management @
1999 -2002 Senior Project Manager @
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 6 emails and 1 mobile phone numbers on RocketReach.
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