Senior Consultant
confinis ag
Frederike Brühschwein-Mandic is a Senior Consultant at confinis ag (Switzerland) since January 2022. At confinis she is responsible for clients with digital health products, navigation products, physical medicine products and many more. She is enabling her clients to implement and pass the MDR requirements as well as supporting them to gain access to the US market by writing pre-submission and 510(k) submissions. Before joining confinis ag as a senior consultant, Frederike worked 11 years in Switzerland for a manufacturer of ventilators (incl. accessories). During this time she conducted as well several usability studies in the US with the products, had pre-PMA discussions with the FDA and successfully lead several audits with the notified body while heading the regulatory and quality department. Frederike moved to Germany in 2020 where she worked in the field of radiology devices as a senior regulatory affairs manager. She obtained her biomedical engineering degree in Hamburg where she spend one year at the University of Utah in the Department of Anesthesiology in the biomedical division where she as well wrote her thesis. During her time in Switzerland, she obtained as well an eMBA at the FH St. Gallen.
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Monday, September 12, 2022
12:00 PM – 12:30 PM MST