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Folker Spitzenberger, PhD, MDRA

Professor for Regulatory Affairs
Technische Hochschule Lübeck Fachbereich Angewandte Naturwissenschaften

Folker Spitzenberger, born in 1970, is a graduate chemist and received his PhD in molecular biology from the Institute of Pharmacology at Heidelberg University. After postdoctoral work at the Medical Faculty of the University of Dresden and at Yale University (CT, USA), he worked from 2002 to 2016 in the area of assessment and implementation of quality assurance systems in the field of medical devices at the ZLG, the RKI and the German accreditation body DAkkS. With the additional qualification as a Master of Drug Regulatory Affairs, he advises international organizations such as the WHO and the EU in the field of QM/QA and Regulatory Affairs. In 2016, Folker Spitzenberger joined the University of Applied Sciences Lübeck (TH Lübeck) as Professor for Regulatory Affairs for medical devices. Since 2021 he leads the Regulatory Affairs department at Fraunhofer IMTE in Lübeck as part of a cooperation between the TH Lübeck and the Fraunhofer-Gesellschaft.

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