Book Detail
Edition: 2nd
Release: 2009-08-17
Publisher: Parexel Intl Corp
Binding: Hardcover
ISBN/ASIN: 1882615921
Format: hardcover, kindle, PDF, EPUB
Medical Device Development pdf
Description
Medical Device Development: Regulation and Law, 2nd Edition, is the must-have resource for the novice or veteran medical device regulatory affairs professional. This practical reference provides the most comprehensive and updated analysis of US medical device and diagnostics development and approval requirements anywhere. This book also features in-depth analysis on how emerging developments and trends are reshaping medical device and combination product regulations in the US. The second edition of this popular and authoritative resource addresses the latest regulatory and legal developments that guide how medical devices are developed today: * The Medical Device User Fee and Modernization Act of 2002, including user fees, third party inspections, reprocessed single use devices, and the establishment of the Office of Combination Products. * The Food and Drug Administration Amendments Act of 2007, including unique device identifiers, ClinicalTrials.gov registration, pediatric device pro Download Medical Device Development for free via rapidshare, mediafire, 4shared, dropBox, uploading, fileserve
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