title: Clinical investigation of medical devices.
abstract: 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.
authors.affiliation: Inveresk Clinical Research Ltd., Edinburgh, UK.
authors.forename: R R
authors.initials: RR
authors.lastname: Stewart
mesh_terms: 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