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The European standard for medical device suppliers. TÜV Rheinland
Group
evaluates suppliers of medical products in accordance with European
standard EN 46001. In accordance with EEC Directives fulfillment
of this standard is the prerequisite for medicine industry products.
It describes the special requirements, which go beyond the standard
ISO 9001 (ISO 9002), that have to be met by the quality management
systems of suppliers. Certification in accordance with EN 46001
is only possible in conjunction with ISO 9001.
Would you like to know more? Then please contact us. We will be
happy to help you.
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