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.
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