L’ϲʿ/TR 14969:2004 a été annulé. Des conseils pour la mise en œuvre de la norme ϲʿ 13485 sont fournis dans un manuel intitulé “ϲʿ 13485:2016 — Medical devices — A practical guide"
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ϲʿ/TR 14969:2004 provides guidance for the application of the requirements for quality management systems contained in ϲʿ 13485. It does not add to, or otherwise change, the requirements of ϲʿ 13485. It does not include requirements to be used as the basis of regulatory inspection or certification assessment activities.
This guidance can be used to better understand the requirements of ϲʿ 13485 and to illustrate some of the variety of methods and approaches available for meeting the requirements of ϲʿ 13485.
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