[PDF.28da] Medical Device Design and Regulation

Medical Device Design and Regulation

[PDF.pp74] Medical Device Design and Regulation

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 | #2059558 in Books |  2011-04-07 | Original language:English | PDF # 1 |  6.25 x9.50 x1.25l,1.60 | File type: PDF | 368 pages

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The intent of this book (MDDR, for short) is to present an introduction to, and overview of, the world of medical device regulation by the United States Food and Drug Administration (FDA), and the relationship of this regulatory scheme to the design and development of medical devices. In providing this information, the book covers the broad range of requirements, which are presented within eight major topics: background and regulatory environment, device design control, ...

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