Methods Inf Med - The integration of the risk management process with the lifecycle of medical device software.

Tópicos

{ data(1714) softwar(1251) tool(1186) }
{ framework(1458) process(801) describ(734) }
{ import(1318) role(1303) understand(862) }
{ implement(1333) system(1263) develop(1122) }
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{ visual(1396) interact(850) tool(830) }
{ medic(1828) order(1363) alert(1069) }
{ decis(3086) make(1611) patient(1517) }
{ featur(3375) classif(2383) classifi(1994) }
{ network(2748) neural(1063) input(814) }
{ learn(2355) train(1041) set(1003) }
{ research(1218) medic(880) student(794) }
{ model(2656) set(1616) predict(1553) }
{ can(981) present(881) function(850) }
{ analysi(2126) use(1163) compon(1037) }
{ detect(2391) sensit(1101) algorithm(908) }
{ patient(2315) diseas(1263) diabet(1191) }
{ chang(1828) time(1643) increas(1301) }
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{ drug(1928) target(777) effect(648) }
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{ method(1969) cluster(1462) data(1082) }
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Resumo

JECTIVES: The application of software in the Medical Device (MD) domain has become central to the improvement of diagnoses and treatments. The new European regulations that specifically address software as an important component of MD, require complex procedures to make software compliant with safety requirements, introducing thereby new challenges in the qualification and classification of MD software as well as in the performance of risk management activities. Under this perspective, the aim of this paper is to propose an integrated framework that combines the activities to be carried out by the manufacturer to develop safe software within the development lifecycle based on the regulatory requirements reported in US and European regulations as well as in the relevant standards and guidelines.METHODS: A comparative analysis was carried out to identify the main issues related to the application of the current new regulations. In addition, standards and guidelines recently released to harmonise procedures for the validation of MD software have been used to define the risk management activities to be carried out by the manufacturer during the software development process.RESULTS: This paper highlights the main issues related to the qualification and classification of MD software, providing an analysis of the different regulations applied in Europe and the US. A model that integrates the risk management process within the software development lifecycle has been proposed too. It is based on regulatory requirements and considers software risk analysis as a central input to be managed by the manufacturer already at the initial stages of the software design, in order to prevent MD failures.CONCLUSIONS: Relevant changes in the process of MD development have been introduced with the recognition of software being an important component of MDs as stated in regulations and standards. This implies the performance of highly iterative processes that have to integrate the risk management in the framework of software development. It also makes it necessary to involve both medical and software engineering competences to safeguard patient and user safety.

Resumo Limpo

jectiv applic softwar medic devic md domain becom central improv diagnos treatment new european regul specif address softwar import compon md requir complex procedur make softwar compliant safeti requir introduc therebi new challeng qualif classif md softwar well perform risk manag activ perspect aim paper propos integr framework combin activ carri manufactur develop safe softwar within develop lifecycl base regulatori requir report us european regul well relev standard guidelinesmethod compar analysi carri identifi main issu relat applic current new regul addit standard guidelin recent releas harmonis procedur valid md softwar use defin risk manag activ carri manufactur softwar develop processresult paper highlight main issu relat qualif classif md softwar provid analysi differ regul appli europ us model integr risk manag process within softwar develop lifecycl propos base regulatori requir consid softwar risk analysi central input manag manufactur alreadi initi stage softwar design order prevent md failuresconclus relev chang process md develop introduc recognit softwar import compon mds state regul standard impli perform high iter process integr risk manag framework softwar develop also make necessari involv medic softwar engin compet safeguard patient user safeti

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