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Safety Evaluation of Medical Devices [Hardcover]

Shayne C. Gad (Author)

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Safety Evaluation in the Development of Medical Devices and Combination Products, Third Edition Safety Evaluation in the Development of Medical Devices and Combination Products, Third Edition
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Book Description

June 15, 1997 0824798279 978-0824798277 1
This practical reference examines the implications of biological and chemical interactions of medical devices with human tissue -- offering comprehensive coverage on the evaluation of safety in specialty devices, medical and surgical supplies, imaging systems, in vitro diagnostics, and health information systems.

Editorial Reviews

Review

Praise for the first edition. . . ....discuss[es]...highly relevant case histories.... ....the quantity of practical information...makes this book very worthwhile.
---Instrumentation Science and Technology --This text refers to an alternate Hardcover edition.

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.

--This text refers to an alternate Hardcover edition.

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Inside This Book (learn more)
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First Sentence:
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). Read the first page
Key Phrases - Statistically Improbable Phrases (SIPs): (learn more)
market approval authority, postnatal development study, first challenge application, cell titre, gravid uterine weight, replicate reaction tubes, typical homopolymer, test group animals, regulatory requirements for medical devices, mouse ear swelling test, cylindrical implants, mouse spot test, leachable materials, maternal body weight gain, embryo bioassay, intercenter agreements, inadvertent contaminants, standard endotoxin, biocompatibility tests, nonirritating concentration, anogenital distance, vaginal microflora, device authorities, implantation test, local lymph node assay
Key Phrases - Capitalized Phrases (CAPs): (learn more)
New York, United States, Mary Ann Liebert, Vitro Toxicology, Marcel Dekker, Boca Raton, Investigation Options, Dose-Response Assessment, Gray Sheet, National Toxicology Program, Cancer Res, Food Chem, San Diego, Cambridge University Press, Cold Spring Harbor, Inter-Center Consultation, Environmental Protection Agency, High High High High Mod, International Conference, Muta Res, Cancer Inst, Current Contents, Medical Device Amendments, United Kingdom, Vitro Fert
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