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CE Marking for Medical Devices
a Handbook to the Medical Devices Directives
The book covers:
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.
306 pages; ISBN 9781559379465