iso 13485 consultants

ISO 13485: 2003

December 20, 2012

ISO 13485: 2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. The key word is consistently. Consistency helps to minimize errors. The consistency be achieved throu... »

Demonstrate your ability to supply medical devices through Quality Management System for Medical Devices – ISO 13485

September 20, 2009

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... »