Beat U. Steffen

Beat U. Steffen, RAC, FRAPS, is the founder and principal consultant of confinis, a consultancy that specializes in regulatory affairs and quality management for the medical device and biotechnology industries. They have served as a Lead Auditor for SQS since 2006 and are currently a Lecturer at sitem-insel AG, where they teach about EU regulatory frameworks. With prior experience as Head of Project & Risk Management at Ypsomed AG and as a Senior Project Manager at Disetronic Medical Systems AG, Beat has developed significant expertise in project and risk management throughout product life cycles. They are also involved as a Special Coach for Regulatory Affairs with Innosuisse and have co-founded Medical Human Factors to enhance usability in medical device development.