The impact of the new quality management system standards on the CE-marking process.
In December 2000, the new ISO 9000 quality management system series of standards was published. This represents a significant development for manufacturers marketing medical devices in Europe, who use these standards to demonstrate conformity to the European medical device Directives. This article discusses some issues related to the introduction of these standards in Europe and their use in the CE-marking process.
Donawa
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Donawa and Associates Ltd, Via Fonte di Fauno 22, I-00153 Rome, Italy. donawa@srd.it
D003257:Consumer Product Safety / Q000592:standards*; D004864:Equipment and Supplies / Q000592:standards*; D005060:Europe; D017408:Guidelines as Topic; D006801:Humans; D011786:Quality Control; D012680:Sensitivity and Specificity