title: Medical device software regulation: an industry perspective.
authors.forename: D
authors.initials: D
authors.lastname: Simons
mesh_terms: D001771:Blood Banks / Q000592:standards*; D006801:Humans; D007221:Industry; D007256:Information Systems / Q000592:standards*; D011785:Quality Assurance, Health Care; D012984:Software / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration