Clinical Evaluation of Medical Devices

Principles and Case Studies

  • Karen Becker Witkin

Table of contents

  1. Front Matter
    Pages i-xi
  2. Fundamentals of Clinical Study Design and Evaluation

    1. Front Matter
      Pages 1-1
    2. Rosanne B. McTyre, Linda M. Pottern
      Pages 23-40
    3. Selma A. Kunitz, Michele Gargano, Rene Kozloff
      Pages 41-58
  3. Introduction to Case Studies

    1. Front Matter
      Pages 79-81
    2. Frederick J. Dorey
      Pages 133-149
    3. Diane E. Mandell, Rosanne B. McTyre, Frank DeLustro, Ross Erickson
      Pages 151-164
    4. Wayne R. Patterson
      Pages 165-189
    5. Roberto Fiorentini, Frank C. Dorsey, Sharon A. Segal, Roland Moskowitz
      Pages 191-207
    6. Ken Stokes
      Pages 233-255
  4. Back Matter
    Pages 257-271

About this book


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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Editors and affiliations

  • Karen Becker Witkin
    • 1
  1. 1.The Weinberg Group, Inc.USA

Bibliographic information