title: Auditing device clinical studies for US requirements.
abstract: Medical device manufacturers conducting clinical studies outside the United States (US) to support US regulatory submissions should be prepared to show that these studies are conducted in a manner that will be acceptable to the Food and Drug Administration. This article discusses the audits that can be conducted to assess this acceptability.
authors: Dona Consulting, Rome, Italy. medonawa@donawa.com
authors: Maria
authors: M
authors: Donawa
mesh_terms: D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence* / Q000592:standards*; D018795:Device Approval / Q000331:legislation & jurisprudence* / Q000592:standards*; D019983:Guideline Adherence / Q000331:legislation & jurisprudence* / Q000592:standards; D008485:Medical Audit / Q000331:legislation & jurisprudence* / Q000592:standards; D014481:United States