BS EN 980 / BS EN 1041 / BS EN ISO 14971/ BS EN ISO 13485 Medical Devices Package specifies the requirements for medical devices information supplied by a manufacturer along with symbols and labeling used in conjunction with that information. This package also provides the application of risk management and quality management systems in association with medical devices. The BS EN 980 / BS EN 1041 / BS EN ISO 14971/ BS EN ISO 13485 Medical Devices Package includes:
BS EN 980:2008
BS EN ISO 13485:2003
BS EN ISO 14971:2009
BS EN 1041:2008