Book: Safety of Electromedical Devices: Law – Risks – Opportunities
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.
Development in the field of medical technology has resulted in a manifold of medical devices enabling us to diagnose illnesses more reliably, treat them more efficiently and compensate for handicaps more effectively. However, these improvements are also associated with safety risks. Today, patients are in contact with an increasing number of medical devices longer and more intensively then before. Applied parts are put into contact with the body, probes may be introduced into the body via natural or surgical orifices, and even whole devices may be implanted for many years. The application of devices is no longer restricted to medical locations only. Home use by lay people is increasing and involves even critical devices such as for dialysis, nerve and muscle stimulation and ventilation.