Clinical evaluation of medical devices : principles and case studies /
In Clinical Evaluation of Medical Devices Karen Becker Witkin and her distinguished colleagues summarize for the first time the key principles and approaches to be used in medical device clinical trials, and then demonstrate the implementation of these principles in a revealing series of detailed, r...
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| Format: | eBook |
| Language: | English |
| Published: |
Totowa, N.J. :
Humana Press,
[1998]
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| Online Access: | Connect to the full text of this electronic book |
| Summary: | In Clinical Evaluation of Medical Devices Karen Becker Witkin and her distinguished colleagues summarize for the first time the key principles and approaches to be used in medical device clinical trials, and then demonstrate the implementation of these principles in a revealing series of detailed, real-world case studies. Building on the techniques used in clinical trials of pharmaceuticals, these highly experienced contributors show how to design and evaluate clinical trials of medical devices, as well as how best to collect data that is acceptable to the FDA. They also explain when, why, and how clinical research fits into the development and marketing of new product concepts and spell out international regulatory requirements for research and registration of medical devices. Nine detailed case studies illustrate the wide range of study designs that have been successfully applied to many different research problems and a variety of therapeutic or diagnostic products. Clinical Evaluation of Medical Devices will not only play a key role in establishing clinical trials of medical devices as a rigorous science, but also provide today's only source of case-study-based practical information on how clinical study design principles are best tailored to the successful evaluation of novel medical devices. |
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| Item Description: | Electronic resource. |
| Physical Description: | 1 online resource (xi, 271 pages) : illustrations |
| Format: | Master and use copy. Digital master created according to Benchmark for Faithful Digital Reproductions of Monographs and Serials, Version 1. Digital Library Federation, December 2002. |
| Bibliography: | Includes bibliographical references and index. |
| ISBN: | 9781475727562 (electronic bk.) 1475727569 (electronic bk.) |