ISO 13485:2004
ISO 13485:2004 Standards specify the Quality System requirements for the manufacturers of Medical Equipment.
Such Standards have been worked out on the pattern of ISO 9001 Standards, supplemented by particular requirements of “Good Manufacturing Practice” (GMP), a widely known subject to the manufacturers of Medical Equipment. ISO 13485 has the task to promote the global harmonisation of mandatory requirements about Medical Devices.
The standard is available for all organisations involved in the planning phase, production, installation and supplying of Medical Devices and related services.
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