Safety of Electromedical Devices [electronic resource] : Law Risks Opportunities / by Norbert Leitgeb.

Medical devices -- How safe is safe enough? -- Application safety -- Biocompatibility -- Hygiene -- Environmental safety -- Ecological safety -- Electric safety -- Electromedical devices -- Safety testing.

The book discusses the legal and technical requirements for manufacturers, designers and testers of electromedical devices. It 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. It explains 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, the book describes which safety requirements are to be met and how they can be satisfied and tested.

ZDB-2-ENG