Clinical investigation of medical devices.
Clinical investigations are required for implantable and invasive devices in Class IIa or IIb, and all Class III devices. This article describes how to successfully perform a clinical trial according to the standards set in EN 540, Clinical Investigation of Medical Devices for Human Subjects.
Stewart
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Inveresk Clinical Research Ltd., Edinburgh, UK.
D002986:Clinical Trials as Topic / Q000379:methods / Q000592:standards*; D003257:Consumer Product Safety / Q000592:standards; D004869:Equipment Safety; D004864:Equipment and Supplies / Q000009:adverse effects / Q000145:classification / Q000592:standards*; D004992:Ethics, Medical; D005060:Europe; D017408:Guidelines as Topic; D006268:Health Facilities; D006801:Humans; D008422:Materials Testing / Q000379:methods* / Q000592:standards; D008991:Monitoring, Physiologic