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SAFETY EVALUATION OF MEDICAL DEVICES
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SAFETY EVALUATION OF MEDICAL DEVICES Hardcover - 2001 - 2nd Edition

by GAD, SHAYNE C

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Details

  • Title SAFETY EVALUATION OF MEDICAL DEVICES
  • Author GAD, SHAYNE C
  • Binding Hardcover
  • Edition number 2nd
  • Edition 2
  • Condition Used - Very Good
  • Pages 504
  • Volumes 1
  • Language ENG
  • Publisher CRC Press
  • Date December 4, 2001
  • Illustrated Yes
  • Bookseller's Inventory # 9780824706173
  • ISBN 9780824706173 / 082470617X
  • Weight 1.94 lbs (0.88 kg)
  • Dimensions 9.26 x 6.26 x 1.26 in (23.52 x 15.90 x 3.20 cm)
  • Library of Congress subjects Toxicity Tests, Biocompatible Materials
  • Library of Congress Catalog Number 2001058401
  • Dewey Decimal Code 681.761

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First line

The medical device industry in the United States and worldwide is immense in its economic impact (sales in 1998 were $138 billion worldwide, and $59 billion in the United States, $34 billion in the European Community, and $23 billion in Japan; in 1998, the U.S. medical equipment trade surplus was $8.7 billion), scope (between 87,000 and 140,000 different devices are produced in the United States by approximately 8200 different manufacturers employing some 311,000 people; it is believed that approximately 1000 of these manufacturers are development-stage companies without products yet on the market), and importance to the health of the world's citizens (Nugent, 1994; the Wilkerson Group, 1999).

About the author

SHAYNE C. GAD is the principal of Gad Consulting Services, Cary, North Carolina, USA. Gad Consulting Services is a 15-year-old consulting firm serving more than 350 clients (including 120 pharmaceutical companies in the US and 35 overseas). Dr. Gad received his B.S. in chemistry and biology from Whittier College, Whittier, California, and his Ph.D. in pharmacology and toxicology from the University of Texas at Austin, Austin, Texas, USA. He has published 39 books and more than 350 chapters, articles, and abstracts in the fields of toxicology, statistics, pharmacology, drug development, and safety assessment. Dr. Gad has more than 30 years of broad-based experience in toxicology, drug and device development, statistics, and risk assessment with specific expertise in neurotoxicology, in vitro methods, cardiovascular toxicology, inhalation toxicology, immunotoxicology, and genotoxicology. He was the past president of the American College of Toxicology and the Roundtable of Toxicology Consultants. Dr. Gad has consulted for the US Food and Drug Administration, Environmental Protection Agency, and the National Institutes of Health.

MARIAN G. MCCORD is Associate Professor with appointments in the Department of Textile Engineering, Chemistry, and Science at North Carolina State University, Raleigh, NC, USA, the Joint UNC/NCSU Department of Biomedical Engineering in Raleigh and Chapel Hill, NC, USA, and an Adjunct Associate Professor of Medicine at the University of North Carolina at Chapel Hill. She serves as co-Director of the Atmospheric Plasma Laboratory at the College of Textiles at NCSU, and is a leader in development of Advanced Medical Technology at NCSU (www.ncsu.edu/amt). Dr. McCord received her M.S. in Bioengineering and Ph.D. in Textiles and Polymer Science from Clemson University, Clemson, South Carolina, USA. She has been active in several professional organizations, including the AAMI Protective Barriers Committee, ASTM F23, the Biomedical Engineering Society, the American Society for Engineering Education, and the Society for Biomaterials. Dr. McCord is the recipient of the 2007 Richard Felder Award for Outstanding Service in Teaching and Learning. She has been an invited lecturer and presenter at numerous consortia, meetings, and conferences, and has been a valued mentor and advisor for her students.