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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

by Shayne C. Gad
 
A practical guide for people charged or concerned with ensuring the safety of medical devices for patients, health care providers, and workers involved in their manufacture. Gad, a consultant based in North Carolina, addresses the basic aspects of regulation and the materials used, and where appropriate the history and underlying science. He also explains processes

Overview

A practical guide for people charged or concerned with ensuring the safety of medical devices for patients, health care providers, and workers involved in their manufacture. Gad, a consultant based in North Carolina, addresses the basic aspects of regulation and the materials used, and where appropriate the history and underlying science. He also explains processes for evaluating the safety of devices and material safety as part of the overall development of new products. Without mentioning a date for the first volume, he says the second incorporates corrections and improvements; changes in the regulations, science, and marketplace; the globalization of devices and regulation; new classes of devices; the exploitation of more scientific disciplines; and the availability of information on the Internet. Annotation c. Book News, Inc., Portland, OR (booknews.com)

Product Details

ISBN-13:
9780824706173
Publisher:
Taylor & Francis
Publication date:
01/28/2002
Edition description:
REV
Pages:
504
Product dimensions:
6.26(w) x 9.26(h) x 1.26(d)

Meet 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.

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