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Frederike Bruehschwein, MA (she/her/hers)

Senior consultant
regular services
München, Germany

Ricky (Frederike) Brühschwein-Mandic, Dipl.-Ing. (FH), eMBA, RAC, is a senior Regulatory Affairs and Quality Management Consultant at regular services. She brings over 17 years of experience in the medical device industry, with leadership and consulting expertise across global regulatory strategy, quality management, and market access for active medical devices. Her background includes FDA submissions, CE marking, MDR implementation, technical documentation, inspection readiness, and support for international approvals in Europe, the United States, Canada, and other markets.

Before moving into consulting, Frederike held senior industry roles at Ziehm Imaging and Hamilton Medical, where she worked at the interface of product development, regulatory compliance, and quality management. Her work included supporting active medical devices through global approval processes, leading regulatory and quality teams, managing audits and inspections, and helping ensure that regulatory requirements were translated into practical and sustainable processes across the organization.

In addition to her industry work, Frederike is Chairwoman of the DIN working group “AI in Medicine,” a member of the RAPS Euro Convergence Conference Committee, and a lecturer at Ansbach University of Applied Sciences.

Presentation(s):

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