Medical Device Vigilance/Monitoring: European Device Directives Compliance - Hardcover

9781574910308: Medical Device Vigilance/Monitoring: European Device Directives Compliance
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Explains the system for monitoring incidents related to medical devices that have been placed on the market as required by directives of the European Union. After outlining the responsibilities of the manufacturer, the user, competent authorities, the European Commission, and notified bodies, discusses classification and conformity concepts, principles and practices of operating a monitoring system, recall policy and procedure, vigilance problems, current national reporting systems, device design, and the European nomenclature system. Provides almost no bibliographic references. Annotation c. by Book News, Inc., Portland, Or.

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  • PublisherInterpharm Pr
  • Publication date1997
  • ISBN 10 1574910302
  • ISBN 13 9781574910308
  • BindingHardcover
  • Edition number1
  • Number of pages198

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