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CE Marking for Medical Devices

a Handbook to the Medical Devices Directives

CE Marking for Medical Devices by C. C. W. Schoenmakers
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The book provides readers with a clear and thorough understanding of the CE Marking procedure for medical devices. After a brief introduction to the EU and the directives, CE Marking for Medical Devices discusses in detail the conformity assessment procedure for the two directives. It covers the structure of the directives, application areas, exceptions and special cases, and implementation methods. The relationship with other directives is also addressed. Together with the use of actual industry examples, it offers practical solutions for ensuring your products conform to the directives.

The book covers:

  • the meaning and consequences of the two directives
  • the relationship between the manufacturer in the US and the importer in the EU
  • distribution, assembly and packaging
  • liability
  • Because the two directives require a quality assurance system, the relationship between the directives and the ISO 9000 system is also discussed. What's more, a chapter is dedicated to describing what steps to take when compiling a manual that manufacturers, exporters and importers can follow when going through the CE Marking procedure.

    Consultants Europe B.V.; January 1997
    306 pages; ISBN 9781559379465
    Download in secure PDF format
    Title: CE Marking for Medical Devices
    Author: C. C. W. Schoenmakers
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