Description

If you are a FDA Medical Device Manufacturing firm that is looking to improve your Quality System by adding ISO 13485:2003 to your list of accreditations/certificat ions, get help!. The certification of a quality management system, specific for Medical Devices will be to your advantage and in many cases is required for organizations who export their products to the global market. ISO 13485:2003 is a stand alone standard specific to medical device quality systems. It contains requirements relating to design controls, process control (including environmental), special processes, traceability, record retention, and regulatory actions which are critical for the medical device industry.

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