Reference number
Ïã¸ÛÁùºÏ²Ê¿ª½±/TR 14969:2004
Technical Report
Ïã¸ÛÁùºÏ²Ê¿ª½±/TR 14969:2004
Medical devices — Quality management systems — Guidance on the application of Ïã¸ÛÁùºÏ²Ê¿ª½± 13485: 2003
Edition 1
2004-10
Withdrawn
Ïã¸ÛÁùºÏ²Ê¿ª½±/TR 14969:2004
33752
Withdrawn (Edition 1, 2004)

Ïã¸ÛÁùºÏ²Ê¿ª½±/TR 14969:2004 was withdrawn. Guidance for the implementation of Ïã¸ÛÁùºÏ²Ê¿ª½± 13485:2016 is provided in a Handbook entitled “Ïã¸ÛÁùºÏ²Ê¿ª½± 13485:2016 — Medical devices — A practical guide"

Abstract

Ïã¸ÛÁùºÏ²Ê¿ª½±/TR 14969:2004 provides guidance for the application of the requirements for quality management systems contained in Ïã¸ÛÁùºÏ²Ê¿ª½± 13485. It does not add to, or otherwise change, the requirements of Ïã¸ÛÁùºÏ²Ê¿ª½± 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 Ïã¸ÛÁùºÏ²Ê¿ª½± 13485 and to illustrate some of the variety of methods and approaches available for meeting the requirements of Ïã¸ÛÁùºÏ²Ê¿ª½± 13485.

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