title: FDA-regulated validation in clinical and nonclinical environments.
authors.forename: Connie
authors.initials: C
authors.lastname: Curts
mesh_terms: D015510:Clinical Medicine / Q000295:instrumentation / Q000592:standards*; D018795:Device Approval; D004282:Documentation / Q000592:standards*; D004864:Equipment and Supplies / Q000592:standards*; D033161:Government Regulation; D019983:Guideline Adherence / Q000592:standards*; D017408:Guidelines as Topic; D012986:Software Validation; D014481:United States; D014486:United States Food and Drug Administration