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Compliance Corner: Medtronic Quality Expert Urges Use Of Problem Statements When Investigating Device Failures – Plus Other Advice

Executive Summary

Problem statements written before failure investigations occur can help device-makers organize their thoughts, fix things right the first time and ensure they aren't barking up the wrong tree, a Medtronic quality expert explains in this "Compliance Corner" feature. Also: a Q&A on CAPA effectiveness checks and root cause.

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