When to conduct a clinical trial.
A clinical trial is designed to provide clinical evidence of compliance with the medical device Directives. Clinical evidence can also be based on systematic and objective literature review. This article highlights when to use the clinical or the literature route to demonstrate the safety and performance of a medical device.
Boutrand
J P
JP
Biomatech SAS, a Namsa Company, Chasse sur Rhône, France. jp.boutrand@biomatech.fr
D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence* / Q000592:standards*; D018795:Device Approval / Q000331:legislation & jurisprudence* / Q000592:standards*; D004869:Equipment Safety / Q000592:standards*; D004864:Equipment and Supplies / Q000592:standards*; D019983:Guideline Adherence; D017408:Guidelines as Topic; D018579:Patient Selection; D011785:Quality Assurance, Health Care / Q000331:legislation & jurisprudence / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration