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Clinical Evaluation of Medical Devices: Principles and Case Studies

by Karen Becker Witkin
Save 35% Save 35%
Current price ₹8,718.00
Original price ₹13,411.00
Original price ₹13,411.00
Original price ₹13,411.00
(-35%)
₹8,718.00
Current price ₹8,718.00

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Book cover type: Paperback
  • ISBN13: 9781617370403
  • Binding: Paperback
  • Subject: N/A
  • Publisher: Springer
  • Publisher Imprint: Humana
  • Publication Date:
  • Pages: 271
  • Original Price: EUR 119.95
  • Language: English
  • Edition: N/A
  • Item Weight: 418 grams
  • BISAC Subject(s): Allied Health Services / Medical Technology, Family & General Practice, and Biotechnology

From the Back Cover
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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