An edition of Safety evaluation in the development of medical devices and combination products
(2008)
Safety evaluation in the development of medical devices and combination products
by Shayne C. Gad
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Safety evaluation in the development of medical devices and combination products
2008, Informa Healthcare USA
in English
1420071645 9781420071641
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Book Details
Table of Contents
Regulatory aspects and strategies in medical device and biomaterials safety evaluation
Road map to test selections
Materials in medical device design / Marian McCord
What to test : sampling and sample preparation
Cytotoxicity testing
Hematocompatibiity
Local tissue tolerance
Immunotoxicology
Implantation biology and studies
Acute systemic testing
Genotoxicity
Subchronic and chronic toxicity and reproductive and developmental toxicity
Carcinogenicity
Degradation products and impurties / Marian McCord
Combination products
Clinical studies for medical devices
Special studies
Toxicokinetics
Case histories and problem resolution.
Edition Notes
Rev. ed. of: Safety evaluation of medical devices / Shayne Cox Gad. 2nd ed., rev. and expanded. c2002.
Includes bibliographical references and index.
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| February 1, 2010 | Edited by WorkBot | add more information to works |
| December 9, 2009 | Created by WorkBot | add works page |