This recommended practice provides information that will allow the medical device data systemmanufacturer to implement a quality management system that is commensurate with the riskpresented by the device, the complexity of device and manufacturing processes, and the size andcomplexity of organization.
AAMI SW87:2012
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Application of quality management system concepts to medical device data systems
Association for the Advancement of Medical Instrumentation , 05/23/2012
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