Performance evaluation and the IVD Directive.
Performance evaluation is a new procedure for many in vitro diagnostics manufacturers. This article describes how to conduct a trial.
Spencer
Sue
S
Cascade Consulting Ltd, Aldershot, UK. sue@cascade-consulting.com
D019411:Clinical Laboratory Techniques / Q000295:instrumentation*; D002986:Clinical Trials as Topic / Q000592:standards; D018795:Device Approval; D004864:Equipment and Supplies / Q000592:standards*; D005060:Europe; D006801:Humans; D066298:In Vitro Techniques; D008422:Materials Testing; D011786:Quality Control