Developing active implantable medical devices in a regulated environment
A. Inmann and J. Spensley, Andreas Inmann Consulting, USA; Finetech Medical, Ltd, UK
Abstract:
In this chapter, we look at the pathway and processes involved in bringing active implantable medical devices to the market, specifically the European Union and the United States of America. We discuss the route to market, the device and its classification, the quality management system and the approval process. Commercializing a novel and innovative active implantable medical device and proving that it is safe to use and does indeed work as specified involves an extensive series of tests and trials, including bench testing, animal studies and human clinical trials. ...
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