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" Medical device safety : "


Document Type : BL
Record Number : 1015574
Doc. No : b769944
Main Entry : Higson, Gordon R.,1932-2001.
Title & Author : Medical device safety : : the regulation of medical devices for public health and safety /\ Gordon R. Higson.
Publication Statement : Bristol, UK ;Philadelphia, PA, USA :: Institute of Physics Pub.,, ©2002.
Page. NO : xiv, 271 pages :: illustrations ;; 25 cm
ISBN : 0750307684
: : 9780750307680
Bibliographies/Indexes : Includes bibliographical references (pages 260-262) and index.
Contents : 1. Introduction -- 2. The transformation in the European Community -- 3. The current situation: the EC Medical Devices Directive -- 4. The current situation: Regulations in USA and Japan -- a comparison with the Medical Devices Directive -- 5. The current situation: regulatory developments in other countries -- 6. The place of quality systems -- 7. The use of product standards -- 8. The question of effectiveness -- 9. Key factors -- post-market controls -- 10. Proposals and prospects for a global regulatory system for medical devices -- 11. Overview and look to the future -- App. 1. Practical steps towards global harmonization -- App. 2. Essential principles of safety and performance of medical devices -- App. 3. Role of standards in the assessment of medical devices -- App. 4. Adverse event reporting guidance for the medical device manufacturer or its authorized representative.
Subject : Medical instruments and apparatus industry-- Law and legislation.
Subject : Medical instruments and apparatus-- Safety regulations.
Subject : Medical instruments and apparatus-- Standards.
Subject : Médecine-- Appareils et instruments-- Industrie-- Droit-- Codes.
Subject : Médecine-- Appareils et instruments-- Normes.
Subject : Médecine-- Appareils et instruments-- Sécurité-- Règlements.
Subject : Medical instruments and apparatus industry-- Law and legislation.
Subject : Medical instruments and apparatus industry-- Law and legislation.
Subject : Medical instruments and apparatus-- Safety regulations.
Subject : Medical instruments and apparatus-- Safety regulations.
Subject : Medical instruments and apparatus-- Standards.
Subject : Medical instruments and apparatus-- Standards.
Subject : Equipment and Supplies-- standards.
Subject : Equipment Safety-- standards.
Subject : Device Approval-- standards.
Subject : Product Surveillance, Postmarketing.
Dewey Classification : ‭610.28‬
LC Classification : ‭K3611.M45‬‭H54 2002‬
NLM classification : ‭2002 A-549‬
: ‭W 26‬‭H634m 2002‬
copyhttps://lib.clisel.com/site/catalogue/1015574
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