Continuous quality assessment of blood glucose monitors (BGMs) is not only of clinical importance, but also a normative argument for evidence-based decision making, in particular for Conformité Européene (CE) marking… Click to show full abstract
Continuous quality assessment of blood glucose monitors (BGMs) is not only of clinical importance, but also a normative argument for evidence-based decision making, in particular for Conformité Européene (CE) marking in Europe. The International Organization for Standardization’s (ISO) directive 151971 provides harmonized procedures and guidelines to ensure international quality standards for BGMs. Here we present a postmarketing evaluation of the CE-marked TD4216 BGM’s system accuracy.
               
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