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ISO/TR 14969:2004

Medical devices -- Quality management systems -- Guidance on the application of ISO 13485: 2003

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Kehtetu alates 24.02.2016
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ISO 14969:1999
ISO/TR 14969:2004 provides guidance for the application of the requirements for quality management systems contained in ISO 13485. It does not add to, or otherwise change, the requirements of ISO 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 ISO 13485 and to illustrate some of the variety of methods and approaches available for meeting the requirements of ISO 13485.

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ISO 13485:2003

Medical devices -- Quality management systems -- Requirements for regulatory purposes
Kehtetu alates 24.02.2016