Managing medical devices within a regulatory framework / edited by Beth Ann Fiedler.

Format
Book
Language
English
Published/​Created
Amsterdam ; Cambridge, MA : Elsevier, [2017]
Description
xxiv, 356 pages : illustrations ; 24 cm

Availability

Available Online

Copies in the Library

Location Call Number Status Location Service Notes
Engineering Library - Stacks R856 .M36 2017 Browse related items Request

    Details

    Subject(s)
    Editor
    Bibliographic references
    Includes bibliographical references and index.
    Contents
    • Reframing Product Life Cycle for Medical Devices / B.A. Fiedler and Y. David
    • Overview of Medical Device Clinical Trials / B.A.Fiedler and M. Ferguson
    • Review Regulatory Guidelines by Device Classification Type / B.A. Fiedler
    • Manufacturing/Distribution Considerations / B.A. Fiedler
    • Defining and Meeting Regulatory Challenges in Clinical Engineering / B.A. Fiedler
    • Roles of Biocompatibility / B.A. Fiedler
    • Risk Management / B.A. Fiedler and A. Farid
    • Sterility and Reusability / B.A. Fiedler
    • European Union National Differences and Potential Impact on CE Marking / B.A. Fiedler
    • Understanding the Transitioning Regulatory EU Market / B.A. Fiedler
    • Evaluating new medical Devices purchases / B.A. Fiedler
    • Evaluating Reimbursement Strategies in the US / B.A. Fiedler and L.J. Greathouse
    • Healthcare Facility Users' Legal Responsibilities and Risks / M. Sanchez
    • Clinical and Biomedical Engineering Evidence Strategy / B.A. Fiedler
    • Device Failure Tracking and Response to Manufacturing Recalls / B.A. Fiedler
    • Health Economics Outcomes Research and Evidence Strategies / M. Ferguson
    • Future of Health Technology Management / B.A. Fiedler
    • Challenges of New Technology: Securing Medical Devices and Their Software for HIPPA Compliance / B.A. Fiedler
    • Managing Smartphone and Tablet Applications / B.A. Fiedler.
    ISBN
    • 9780128041796 (paperback)
    • 012804179X (paperback)
    OCLC
    961004431
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