Managing medical devices within a regulatory framework

by Fiedler, Beth Ann

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Title Statements

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

Edition Statements

Publication Date:2017

Publication Statements

Publisher(s):Elsevier
Place of Publication:Amsterdam
Language:eng
Publication Date:2017

The Physical Object

Description:xxiv, 356 pages : : illustrations ; : 24 cm

Edition Identifiers

ISBN:9780128041796, 012804179X
oclc:ocn961004431
LC Classification:R856
Dewey Decimal:610.284

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 Tech…

Subjects

Equipment and Supplies Equipment Safety -- standards Government Regulation Médecine -- Appareils et instruments Medical Device Recalls -- standards Medical instruments and apparatus -- Ma… Technology Assessment, Biomedical -- tr…