Medical Devices and in Vitro Diagnostics: Requirements in Europe (Reference Series in Biomedical Engineering) [Hardcover] [Aug 27, 2023] Baumgartner, Christian; Harer, Johann and Schröttner, Jörg

From 2000-2003 Dr. Schröttner held a research and teaching assistant position at the Institute of Biomedical Engineering at Graz University of Technology, Austria. From 2003-2008 he was deputy head of the Institute of Clinical Engineering with European Notified Body (PMG), where he developed the conformity assessment procedures of quality management systems for active medical devices according to the medical device directives. Since 2008 he is the deputy head of the Institute of Health Care Engineering and in 2014 he became the head of the European Testing Center of Medical Devices, formerly European Notified Body. In view of current socio-demographic developments, Dr. Schröttner’s scientific work deals with methodological, technical,  organizational, economic and quality assuring aspects of intra- and extramural health care, with a special focus on patient safety. The goal is to help patients cure or alleviate their illness efficiently, economically, without adverse events and in a quality-assured manner. He is the author of more than 100 publications in reviewed journals, books and conference proceedings, and patents. Dr. Schröttner has also been active in the field of medical device approval at the state-accredited Testing and Certification Body for Medical Devices for over 20 years. He is an expert in the development, manufacturing and testing of active medical devices and is lead auditor for quality management systems according to EN ISO 13485 and EN ISO 9001.