Safety evaluation in the development of medical devices and combination products
By: by Shayne C. Gad, Marian G. McCord.
Contributors: McCord, Marian G.; Gad, Shayne C., 1948-
Publisher: Informa Healthcare USA
Published: 2008
Place of publication: New York, NY
Language: eng
ISBN-13: 9781420071641
Subjects: Biomedical materials -- Testing; Biomedical materials -- Toxicity testing; Biocompatibility -- Testing; Biocompatible Materials; Materials Testing; Equipment Failure; Equipment Safety; Toxicity Tests
Notes: Rev. ed. of: Safety evaluation of medical devices / Shayne Cox Gad. 2nd ed., rev. and expanded. c2002.

Includes bibliographical references and index.
Table of contents: title: Regulatory aspects and strategies in medical device and biomaterials safety evaluation; title: Road map to test selections; title: Materials in medical device design / Marian McCord; title: What to test : sampling and sample preparation; title: Cytotoxicity testing; title: Hematocompatibiity; title: Local tissue tolerance; title: Immunotoxicology; title: Implantation biology and studies; title: Acute systemic testing; title: Genotoxicity; title: Subchronic and chronic toxicity and reproductive and developmental toxicity; title: Carcinogenicity; title: Degradation products and impurties / Marian McCord; title: Combination products; title: Clinical studies for medical devices; title: Special studies; title: Toxicokinetics; title: Case histories and problem resolution.