ISO/TR 14969 Available with Guidance on ISO 13485

ISO/TR 14969:2004 is available with guidance for the application of the medical device requirements contained in ISO 13485:2003. It does not add to, or change, the requirements of ISO 13485. The 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 its requirements.

This new standard can be ordered through ANSI for $137 at: <>.