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Clinical Evaluation Of Medical Devices, 2/E: Principles And Cases Studies at Meripustak

Clinical Evaluation Of Medical Devices, 2/E: Principles And Cases Studies

Books from same Author: Karen M. Becker    John J. Whyte

Books from same Publisher: Humana Press Inc.

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    • General Information  
    Author(s)Karen M. Becker    John J. Whyte
    PublisherHumana Press Inc.
    Edition2nd ed. 2006
    ISBN9781588294227
    Pages360
    BindingHardback
    LanguageEnglish
    Publish YearDecember 2005

    Description

    Humana Press Inc. Clinical Evaluation Of Medical Devices, 2/E: Principles And Cases Studies by Karen M. Becker    John J. Whyte

    The original edition of this text Clinical Evaluation of Medical Devices: Principles and Case Studies provided the first overview of key pr- ciples and approaches to medical device clinical trials illustrated with a series of detailed real-world case studies. The book is designed as a resource for clinical professionals and regulatory specialists working in the field of new medical device development and marketing. Since the first edition of this text was published in 1997 the rapid pace of inno- tion in health care technologies continues to yield exciting and important new products. The regulatory landscape has also evolved reflecting some of the changes and needs within the medical device industry. The purpose of Clinical Evaluation of Medical Devices: Principles and Case Studies Second Edition is to provide an updated and expanded presentation of the scientific methods and regulatory requirements applied to the study of new significant risk medical devices. The text now includes (1) new information on the requirements and process for gaining reimbursement of new products from Medicare and private insurers with case studies of research specifically designed for this p- pose as well as health care technology assessment methods; (2) infor- tion on new statistical methodologies applied to medical device trials; and (3) all new case studies including examples of combination pr- ucts three-phase development models (i. e. feasibility FDA approval Medicare reimbursement) and novel study designs.