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ISO 13485 / 14971 / 14969 - Medical Devices Package

     

ISO 13485 / 14971 / 14969 - Medical Devices Package

The ISO 13485 / 14971 / 14969 - Medical Devices Package provides regulatory requirements for quality management medical device systems and incorporating and maintaining a risk management system accociated with the use of medical devices. This package includes:
ISO 13485:2016
ISO 14971:2007
ISO/TR 14969:2004 Historical Document

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