This document provides a mapping of the US FDA 21 CFR requirements to the “regulatory requirements” references in ISO 13485:2016. This mapping is intended to be a tool for US industry to help identify the regulatory requirements from the US medical device regulations to be addressed through an ISO 13485 quality management system.
AAMI TIR102:2019
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U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems
Association for the Advancement of Medical Instrumentation , 08/30/2019
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