Giving you support and advice in the implementation of a quality management system for medical devices
This Technical Report provides guidance for the application of BS EN ISO 13485. It can be used to better understand the requirements of BS EN ISO 13485 and to illustrate some of the variety of methods and approaches available for meeting best practice guidelines.
The guidance is applicable to the design, development, production, installation and servicing of medical devices of all kinds.
The principles and examples contained in PD CEN ISO/TR 14969:2005 can be useful as background information for those representing quality management system assessors, Conformity Assessment Bodies and regulator enforcement bodies.