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Guest Column: Don't Let These 2 Quality Nightmares Keep You Up At Night

This article was originally published in The Gray Sheet

Executive Summary

Former CDRH Office of Compliance Director Steve Silverman advises device manufacturers to address two common "quality nightmares": competitors passing them by as they address quality issues and regulatory enforcement actions that can cause them to fall behind other firms. "Good quality doesn't just save device-makers from less-than-baseline compliance; in fact, good quality usually saves money due to fewer compliance deviations," Silverman writes along with his McKinsey & Co. colleagues David Keeling, Enno de Boer and Ted Fuhr in this "Gray Sheet" Medtech Talk column.

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