title: Risk-based validation of multilingual medical devices.
authors.affiliation: SoftwareCPR, USA.
authors.forename: Alan
authors.initials: A
authors.lastname: Kusinitz
authors.forename: Kai
authors.initials: K
authors.lastname: Simonsen
mesh_terms: D018795:Device Approval / Q000592:standards*; D004864:Equipment and Supplies / Q000592:standards*; D038622:Internationality; D019303:Multilingualism; D018570:Risk Assessment / Q000592:standards*; D012307:Risk Factors; D012984:Software / Q000592:standards*; D012986:Software Validation