

Prof. Dr. Folker Spitzenberger
Professor at the University of Applied Sciences, Luebeck, GermanyProfessor for regulatory affairs and quality management for medical devices at the University of Applied Sciences, Luebeck, Germany. Since 2005 until he has been working as a(n) consultant, scientific expert, advisor for WHO, EU, PTB and other organizations in numerous international projects related to regulatory affairs, quality assurance, quality management, biosafety/biosecurity, accreditation/certification and standardization of medical/health laboratories. He has International work experience as senior scientist, quality assessor and quality expert for all kinds of quality systems related to the in vitro diagnostic medical devices (IVDMD) sector including branches as accreditation and designation, certification and GMP, risk assessment and vigilance, disease control and prevention.
Posted on 24.04.2019
Regulatory affairs: One way of addressing the skill shortage Notified Bodies are facing


By Prof. Dr. Folker Spitzenberger, Professor at the University of Applied Sciences, Luebeck, Germany