عنوان

Medical device safety :

0750307684

9780750307680

b769944

Medical device safety :

[Book]

the regulation of medical devices for public health and safety /

Gordon R. Higson.

Philadelphia, PA, USA :

Institute of Physics Pub.,

©2002.

xiv, 271 pages :

illustrations ;

25 cm

Includes bibliographical references (pages 260-262) and index.

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.

0

Medical instruments and apparatus industry-- Law and legislation.

Medical instruments and apparatus-- Safety regulations.

Medical instruments and apparatus-- Standards.

Device Approval-- standards.

Equipment and Supplies-- standards.

Equipment Safety-- standards.

Product Surveillance, Postmarketing.

Médecine-- Appareils et instruments-- Industrie-- Droit-- Codes.

Médecine-- Appareils et instruments-- Normes.

Médecine-- Appareils et instruments-- Sécurité-- Règlements.

Medical instruments and apparatus industry-- Law and legislation.

Medical instruments and apparatus industry-- Law and legislation.

Medical instruments and apparatus-- Safety regulations.

Medical instruments and apparatus-- Safety regulations.

Medical instruments and apparatus-- Standards.

Medical instruments and apparatus-- Standards.

Higson, Gordon R.,1932-2001.

20201206161604.0

[Book]

Y