title: Validation and Six Sigma.
abstract: Medical device design and manufacturing organizations, and their suppliers, that are pursuing operational excellence are urged to employ Six Sigma. It is a validation activity that addresses risk and by harnessing this methodology companies can accelerate and improve their risk management. This article explains how.
authors.affiliation: ARV Excellence Ltd., Limerick, Ireland. eoin@arvexcellence.com
authors.forename: Eoin
authors.initials: E
authors.lastname: Barry
mesh_terms: D004864:Equipment and Supplies / Q000592:standards*; D005060:Europe; D019983:Guideline Adherence / Q000592:standards*; D017408:Guidelines as Topic; D007221:Industry / Q000592:standards*; D011358:Product Surveillance, Postmarketing / Q000592:standards*; D011786:Quality Control