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Safety evaluation in the development of medical devices and combination products / Shayne C. Gad, Marian G. McCord.

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Author/Creator:
Gad, Shayne C., 1948-
Language:
English.
Publication date:
2008
Imprint:
3rd ed. - New York : Informa Healthcare, c2008.
Format:
  • Book
  • viii, 300 p. : ill. ; 29 cm.
Note:
Rev. ed. of: Safety evaluation of medical devices / Shayne Cox Gad. 2nd ed., rev. and expanded. c2002.
Bibliography:
Includes bibliographical references and index.
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 toxicity testing device safety evaluation
  • 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 in biomaterial and device safety evaluation
  • Case histories and problem resolution.
Contributor:
McCord, Marian G.
Related Work:
Gad, Shayne C., 1948- Safety evaluation of medical devices.
Subjects:
ISBN:
9781420071641
1420071645

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