Si trattano maggiormente gli aspetti implementativi, attraverso l'illustrazione delle scelte progettuali adottate sul campo per far fronte alle sfide del settore, fornendo esempi concreti di implementazione.
1 progetto software su 6 sfora il budget del 200% e i tempi del 70% Flyvbjerg B., Why Your IT Project May Be Riskier Than You Think, Harvard Business Review, September 2011:3-4Monday, October 29, 2012
DIRECTIVE 2007/47/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L: 2007:247:0021:0055:en:PDFMonday, October 29, 2012
(6) It is necessary to clarify that software in its own right, when specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of a medical device, is a medical device. Software for general purposes when used in a healthcare setting is not a medical device.Monday, October 29, 2012
(20) Taking account of the growing importance of software in the field of medical devices, be it as stand alone or as software incorporated in a device, validation of software in accordance with the state of the art should be an essential requirement.Monday, October 29, 2012
IEC 62304 Medical device software – Software life cycle processesMonday, October 29, 2012