Courtesy: PD ISO/TR 14969:2004 The guidance given in this Technical Report is applicable to the design, development, production,installation and servicing of medical devices of all kinds. It describes concepts and methods that can beconsidered by organizations which are establishing and maintaining quality management systems. Guidance contained in this Technical Report can be useful as background […]
Category Archives: PD ISO/TR 14969:2004
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.
Additional Information:
- Item Code: ISO1
- Pay Mode Terms: T/T (Bank Transfer),D/A