Demonstrate your ability to supply medical devices through Quality Management System for Medical Devices – ISO 13485
ISO 13485 is the quality management system standard for medical devices. This standard applies the ISO 9001:2008 process approach to quality, and replaces ISO 13485:1996 and ISO 13488:1996. ISO 13485:2003 provides an effective base model for compliance with the EU CE marking Medical Devices Directives requirements. ISO 13485:2003 is also considered to be fully compatible with the FDA QSR. ISO 13... »
