Prof. Dr. Folker Spitzenberger
Professor at the University of Applied Sciences, Luebeck, Germany
Professor 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.
1 blog from the author
Posted on 24.04.2019
Regulatory affairs: One way of addressing the skill shortage Notified Bodies are facing
New EU Regulations on medical devices and in vitro diagnostic medical devices (IVDs) mean all stakeholders, including manufacturers, competent authorities, and Notified Bodies – need new knowledge and skills. The Regulations seek to harmonise requirements, capacities and competencies of Notified Bodies and to me, one of the key advances is the new responsibilities for Notified […]