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Author Gad, Shayne C., 1948-
Title Safety evaluation in the development of medical devices and combination products [electronic resource] / Shayne C. Gad, Marian G. McCord
Imprint New York : Informa Healthcare, c2008
book jacket
Edition 3rd ed
Descript viii, 300 p. : ill
Note Rev. ed. of: Safety evaluation of medical devices / Shayne Cox Gad. 2nd ed., Rev. and expanded. c2002
Includes bibliographical references and index
Regulatory aspects and strategy in medical device and bio materials safety evaluation -- Road map to test selections -- Materials in medical device design -- What to test : sampling and sample preparation -- Cytotoxicity testing -- Hematocompatibiity -- Local tissue tolerance -- Immunotoxicology -- Implantation biology and studies -- Acute systemic testing device safety evaluation -- Genotoxicity -- Subchronic and chronic toxicity and reproductive and developmental toxicity -- Carcinogenicity -- Degradation products and impurties -- Combination products -- Clinical studies for medical devices -- Special studies -- Toxicokinetics in biomaterial and device safety evaluation -- Case histories and problem resolution
Also available in print edition
Mode of access: World Wide Web
Link 9781420071641
1420071645
9781439809488
Subject Biomedical materials -- Testing
Biomedical materials -- Toxicity testing
Biocompatibility -- Testing
Electronic books. lcsh
Alt Author McCord, Marian G
Gad, Shayne C., 1948- Safety evaluation of medical devices
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