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- W103528015 abstract "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. When the device finally reaches the market, its manufacturer still has obligations to maintain feedback from the market environment. We conclude with how the applicable processes and the commercialization strategy are influenced by the regulatory environment." @default.
- W103528015 created "2016-06-24" @default.
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- W103528015 date "2013-01-01" @default.
- W103528015 modified "2023-09-25" @default.
- W103528015 title "Developing active implantable medical devices in a regulated environment" @default.
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- W103528015 doi "https://doi.org/10.1533/9780857096289.2.299" @default.
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