Safety of Electromedical Devices ― Law - Risk - Opportunities

In his new book, Norbert Leitgeb discusses the legal and technical requirements for manufacturers, designers and testers of electromedical devices. He describes which obstacles must be overcome to introduce a medical device on the European market, but also informs readers as to pitfalls and opportunities, and in which way safety can be achieved and product liability limited. Leitgeb explains comprehensively how the newly required risk management process, which comprises risk analysis, risk assessment, risk management and risk control, can be implemented. As a final essential consideration, he describes which safety requirements are to be met and how they can be satisfied and tested.

Prof. Dipl.-Ing. Dr. Norbert Leitgeb is head of the Institute of Health Care Engineering at Graz University of Technology, Austria, and head of the European Notified Body of Medical Devices, PMG. His work areas comprise safety technology in regard to medical safety and patient's safety, biologic effects of non-ionising electromagnetic fields including field measurement and numerical dosimetry, risk assessment, risk perception and risk communication as well as analysis, development and assessment of new approaches for health care.