title: Medical device software: a new challenge.
abstract: The application of software in the medical device domain has become central to improve diagnoses and treatments. The introduction of new regulations poses issues for the qualification and classification of MD software and requires complex procedures to make them complaint with safety requirements. The paper focuses on EU, Canada and US regulations, standards and guidelines and in particular highlights the integration of the risk management process with the software lifecycle.
authors.affiliation: National Research Council, Institute for Research on Population and Social Policies, Rome, Italy. d.luzi@irpps.cnr.it
authors.forename: Daniela
authors.initials: D
authors.lastname: Luzi
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Pecoraro
mesh_terms: D004864:Equipment and Supplies / Q000592:standards*; D017408:Guidelines as Topic; D038622:Internationality; D012308:Risk Management / Q000331:legislation & jurisprudence / Q000592:standards; D012984:Software / Q000331:legislation & jurisprudence* / Q000592:standards*