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AAMI SW87:2012

M00002662

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AAMI SW87:2012 Application of quality management system concepts to medical device data systems

standard by Association for the Advancement of Medical Instrumentation, 05/23/2012

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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.