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Princeton University Library Catalog
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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
Knovel Complete Academic
Copies in the Library
Location
Call Number
Status
Location Service
Notes
Engineering Library - Stacks
R856 .M36 2017
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Details
Subject(s)
Medical instruments and apparatus
—
Management
[Browse]
Editor
Fiedler, Beth Ann
[Browse]
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.
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ISBN
9780128041796 (paperback)
012804179X (paperback)
OCLC
961004431
Statement on language in description
Princeton University Library aims to describe library materials in a manner that is respectful to the individuals and communities who create, use, and are represented in the collections we manage.
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Managing medical devices within a regulatory framework / edited by Beth Ann Fielder.
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