LSA2019 - Lübeck Summer Academy on Medical Technology
Our topics are regulatory affairs for medical devices, and artificial intelligence / deep learning. Transition to the Medical Device Regulation (MDR) continues to be the dominating topic in the medical device industry. The designation process of notified bodies (NB) in accordance with the MDR remains ongoing. In our session on Regulatory Affairs we will try to give an overview on the state of play, and will examine a number of particular aspects, including the role of the new qualified person and the impact of the MDR on Over-the-Counter (OTC, or borderline) products. Also included is a report on experiences of a medical device start-up with European and US regulations. The session is organised by Life Science Nord’s Working Group on Regulatory Affairs. In 2017 we first included Artificial Intelligence (AI) as a topic into LSA. Since then, our Working Group on AI has discussed both emerging and already implemented applications in the regional industry, research organisations and universities. Besides technological aspects, ethical issues remain an important matter of the discussion, particularly when health applications come into play. This year’s AI session at LSA describes a number of novel AI-based medical applications, and highlights how ethical concerns in system design gradually advance into legal guidelines and industry standards. The session is co-organised by Fraunhofer MEVIS and the Institute for Electrical Engineering in Medicine of the University of Lübeck.