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FDAs Transition from CFR 820 to the ISO 13485:2016 Instituting a New Quality Management System (QMS) FDAs shift to a Quality System Regulation structure of ISO 13485:2016 is an effort to harmonize medical device regulations as well as reduce compliance and record keeping burdens faced by current medical device manufacturers

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Cohens f 2 of 0.02, 0.15, and 0.35 indicates a small, medium, and large effect size, respectively 32