Sinossi
Book by Jonathan S Kahan
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Medical Device Development: Regulation and Law
Da: HPB-Red, Dallas, TX, U.S.A.
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hardcover. Condizione: Good. Connecting readers with great books since 1972! Used textbooks may not include companion materials such as access codes, etc. May have some wear or writing/highlighting. We ship orders daily and Customer Service is our top priority! Codice articolo S_424768719
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Medical Device Development: Regulation and Law
Editore:
Parexel International Corporation, 2009
ISBN 10: 1882615921
ISBN 13: 9781882615926
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Da: ThriftBooks-Dallas, Dallas, TX, U.S.A.
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Hardcover. Condizione: Very Good. No Jacket. Missing dust jacket; May have limited writing in cover pages. Pages are unmarked. ~ ThriftBooks: Read More, Spend Less. Codice articolo G1882615921I4N01
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Foto dell'editore
Medical Device Development: Regulation and Law
Editore:
Parexel International Corporation, 2009
ISBN 10: 1882615921
ISBN 13: 9781882615926
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Rilegato
Da: ThriftBooks-Dallas, Dallas, TX, U.S.A.
Valutazione del venditore 5 su 5 stelle
Hardcover. Condizione: Very Good. No Jacket. May have limited writing in cover pages. Pages are unmarked. ~ ThriftBooks: Read More, Spend Less. Codice articolo G1882615921I4N00
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Medical Device Development: Regulation and Law
Editore:
Parexel International Corporation, 2009
ISBN 10: 1882615921
ISBN 13: 9781882615926
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Da: ThriftBooks-Reno, Reno, NV, U.S.A.
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Hardcover. Condizione: Very Good. No Jacket. May have limited writing in cover pages. Pages are unmarked. ~ ThriftBooks: Read More, Spend Less. Codice articolo G1882615921I4N00
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EUR 34,69
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Foto dell'editore
Medical Device Development: Regulation and Law
Editore:
Parexel International Corporation, 2009
ISBN 10: 1882615921
ISBN 13: 9781882615926
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Rilegato
Da: ThriftBooks-Dallas, Dallas, TX, U.S.A.
Valutazione del venditore 5 su 5 stelle
Hardcover. Condizione: Good. No Jacket. Pages can have notes/highlighting. Spine may show signs of wear. ~ ThriftBooks: Read More, Spend Less. Codice articolo G1882615921I3N00
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EUR 34,69
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Medical Device Development: Regulation and Law
Editore:
Parexel International Corporation, 2009
ISBN 10: 1882615921
ISBN 13: 9781882615926
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Rilegato
Da: ThriftBooks-Atlanta, AUSTELL, GA, U.S.A.
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Hardcover. Condizione: Very Good. No Jacket. May have limited writing in cover pages. Pages are unmarked. ~ ThriftBooks: Read More, Spend Less. Codice articolo G1882615921I4N00
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Medical Device Development: Regulation and Law
Da: World of Books (was SecondSale), Montgomery, IL, U.S.A.
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Condizione: Very Good. Item in very good condition! Textbooks may not include supplemental items i.e. CDs, access codes etc. Codice articolo 00102640633
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Medical Device Development: Regulation and Law
Da: Feldman's Books, Menlo Park, CA, U.S.A.
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Hardcover. Condizione: Fine. 2nd Edition. Codice articolo 045598
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MEDICAL DEVICE DEVELOPMENT: REGULATION AND LAW
Da: WONDERFUL BOOKS BY MAIL, CHICO-CA, CA, U.S.A.
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Hardcover. Condizione: Very Good. Second Edition". VERY GOOD CONDITION, I noticed 3 sentences yellow hilited, ow it is solid,bright, appears to be unread ; WHITE TITLES ON black HARD COVERS, showing 3 photos and large x ray view of electronic implant ; 550 pages; The design and functional complexity of medical devices and systems has increased during the past half century, evolving from the level of cardiac pacemakers to magnetic resonance imaging devices. Such life-saving advancements are monumentally advantageous, but with so much at stake, regulation & laws are inevitable. 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 promotion, and postmarket surveillance and medical device reporting changes. * The current and future landscape of electronic 510(k) and PMA submissions. New chapters and features in the second edition include: * Medical Device Compliance and Postmarket Surveillance requirements. * Quality System Regulation, including management controls, design controls, risk analysis and corrective and preventive action, and other QSR provisions. * In Vitro Diagnostics, including IVD clinical studies, ASR regulation, LDTs, CLIA, and IUO/RUO requirements. * Combination Products and Product Jurisdiction, including a description of FDA s jurisdictional decision-making for single entity products, Codice articolo 128584
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Medical Device Development: Regulation and Law
Da: Revaluation Books, Exeter, Regno Unito
Valutazione del venditore 5 su 5 stelle
Hardcover. Condizione: Brand New. 2nd edition. 550 pages. 9.30x6.50x1.60 inches. In Stock. Codice articolo 1882615921
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