title: Software validation.
abstract: This article examines the requirements of EN 60601-1-4, which states that risk management is an integral part of the development of software for medical devices. Food and Drug Administration regulations are also compared to the requirements of the Medical Device Directive to provide guidance on developing software for the European and US markets.
authors.affiliation: EUROSPEC GmbH, Darmstadt, Germany.
authors.forename: H
authors.initials: H
authors.lastname: Wenner
mesh_terms: D004864:Equipment and Supplies; D005060:Europe; D017408:Guidelines as Topic; D006801:Humans; D012308:Risk Management; D012986:Software Validation; D014481:United States; D014486:United States Food and Drug Administration