Regulatory Affairs Manager
Fraunhofer IMTE
Charlott Danielson is a professional engineer specializing as a Regulatory Affairs Manager in the medical device industry and is affiliated with Fraunhofer IMTE for collaborative research. She earned her B.Sc. in Medical Engineering Science from the University of Lübeck, Germany, and her M.Sc. in Regulatory Affairs from the Technical University of Applied Sciences Lübeck, Germany. During her academic pursuits, Charlott Danielson concentrated on mathematics and its applications in life sciences, delving deeply into Quality and Regulatory Affairs for medical devices. Her research also encompassed mathematical lung modeling.
Her professional journey led her into both the medical device industry and research. She has years of experience in various international regulatory fields of medical device manufacturers, including post-market surveillance and vigilance, conformity assessment procedures, and medical device submissions and approvals. Furthermore, she joined the Fraunhofer Research Institution for Individualized and Cell-Based Medical Engineering (IMTE) in Lübeck, Germany, to further concentrate on computational modeling and simulation in the field of medical devices while considering regulatory frameworks and is also involved in corresponding standardization activities. Specifically, she focuses on regulatory compliant (pre-)clinical assessments of medical devices based on in silico methods.
Disclosure information not submitted.
Tuesday, May 7, 2024
16:45 – 17:45 CEST