ISO TR 14969 PDF Free Download: An Essential and Insightful Guidance on ISO 13485:2003 for Medical D

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.

The 2003 edition of ISO 13485 has now been withdrawn and fully replaced by the 2016 edition.[i] As a result, a technical report on the 2003 edition, ISO TR 14969, also was withdrawn and replaced by a new ISO handbook, ISO 13485:2016 A practical guide,[ii] released in 2017. An earlier Med Device Online article discussed some of the issues these changes caused for small device companies.[iii]

iso tr 14969 pdf free download

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