seminario federico caboni, 25-10-2012
DESCRIPTION
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.TRANSCRIPT
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Standard internazionali e linee guida per il software nel settore della salute
Federico Caboni - [email protected]
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1 progetto software su 6sfora 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 2011:3-4
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DIRECTIVE 2007/47/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 5 September 2007amending 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:PDF
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(6) It is necessary to clarify that software in its own right, when speci!cally intended by the manufacturer to be used for one or more of the medical purposes set out in the de!nition of a medical device, is a medical device. Software for general purposes when used in a healthcare setting is not a medical device.
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(20) Taking account of the growing importance of software in the !eld 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.
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IEC 62304Medical device software – Software life cycle processes
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Metodologia
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ricerca e sviluppocreazione di nuovi prodotti, servizi, ecc.
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1. agilità2. collaborazione3. qualità
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1. agilità
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Design Implement Test
Waterfall
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Costo di soluzione di un difetto
tempo
cost
o
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Costo di soluzione di un difetto
tempo
cost
o
design implement test
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Design Implement
Test
Iterativo
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Iterativo
1asettimana
2asettimana
3asettimana
4asettimana
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Iterativo
1aiterazione
2aiterazione
3aiterazione
4aiterazione
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misurarenumero di bug, tempo medio di soluzione, ecc.;usare le misurazioni subito per correggere la rotta.
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prototipipiani!ca di gettarne via (almeno) uno.
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改善Monday, October 29, 2012
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2. collaborazione
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stakeholderspossono essere numerosi e eterogenei.
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scrivilo!scrivere subito una bozza e migliorare;usare strumenti con poco attrito (ad es. wiki).
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versioninggit, mercurial, svn... o per!no cvs;chi ha fatto cosa? quando? come torno indietro?
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tener traccia dei difetticome si riproduce;cosa succede;cosa dovrebbe succedere;meglio un !le excel condiviso che niente.
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3. qualità
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unit testprovano una funzione/unità per volta;si scrivono mentre si implementa (o prima! -TDD);si usano anche come test di regressione.
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black box testingprovare il software dall'esterno;integrare continuamente, e provare l'integrazione;coinvolgere gli utenti il prima possibile.
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fuzz testingil mondo reale non è deterministico;nemmeno il testing dovrebbe esserlo;vedi, ad esempio zzuf.
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automatizzaredeve essere possibile lanciare i test in un comando;oltre ai test automatizzare tutto il resto.
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Brooks, Fred P. (1986). "No Silver Bullet — Essence and Accident in Software Engineering". Proceedings of the IFIP Tenth World Computing Conference: 1069–1076.
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unit testing
sviluppo iterativo
bug tracking
code review
versioning
wiki
integration testing
fuzz testing
automated building
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