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Implantable Sensor Systems for Medical Applications
book

Implantable Sensor Systems for Medical Applications

by A Inmann, D Hodgins
January 2013
Intermediate to advanced
544 pages
16h 50m
English
Woodhead Publishing
Content preview from Implantable Sensor Systems for Medical Applications
10

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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Publisher Resources

ISBN: 9781845699871