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Demonstrate your ability to supply medical devices through Quality Management System for Medical Devices – ISO 13485
September 20th, 2009
ISO Certification Consultants 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 13485 is an international standard, recognized throughout the world for establishing a business management system specific to the medical device industry. ISO 13485 is applicable to organizations that manufacture private label medical devices, in vitro diagnostic medical devices, and medical components.




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