| Document Date: 2012-11-13 17:52:35
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Company SG2 / Authoring Group / Quality Management Systems / / IndustryTerm medical device manufacturer / lowest risk devices / rigorous audit / to all products / subsequent regulatory audit / regulatory systems / voluntary / compliant device / local distributor / device manufacturer / / Organization Regulatory Authority / Global Harmonization Task Force / / Person Roland Rotter / / Position Chair / Representative / Secretary of GHTF Study Group / Chairman / General / regulatory model for IVD medical devices / / PublishedMedium Conformity / /
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Principles of Conformity Assessment for IVD Medical Devices SG1 Final Document GHTF/SG1/N046:2008 GHTF/SG1/N046:2008