FDA software policy and regulation of medical device software.
Crumpler
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ES
Center for Devices and Radiological Health, Food and Drug Administration, USA.
Rudolph
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H
D004864:Equipment and Supplies / Q000592:standards; D006801:Humans; D007883:Legislation, Medical; D011640:Public Policy; D012984:Software / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration