Folker Spitzenberger

Professor for Regulatory Affairs for medical devices at Unversity of Applied Sciences Lübeck

Speaker

Folker Spitzenberger is a graduate chemist and received his PhD in molecular biology. After postdoctoral work at 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 in the field of QM/QA and Regulatory Affairs. In 2016, Folker Spitzenberger joined the University of Applied Sciences Lübeck (TH Lübeck) where he represents the section of Regulatory Affairs for medical devices. Folker Spitzenberger actively joins various standardization committees and is co-author of many standards in the field of quality and risk management and biomedical engineering.