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...The medical device industry projected b more than companies less people case for quality began dialogue focus on compliance vs product measurement and transparency culture regulation does not prescribe in detail how a manufacturer must produce specific rather provides framework that all manufacturers follow by requiring develop procedures fill details regulations provide what of capa part corrective preventive action establish maintain investigating cause nonconformities identifying needed verifying or validating implementing recording changes containment interim problem solving dmaic d whys fishbone diagrams project management metrics reward recognition...