Um Mapeamento do MPS.Br para o Desenvolvimento de Dispositivos Médicos com Foco em Engenharia de Requisitos
Resumo
Todos os Dispositivos Médicos precisam atender às regulamentações para garantir a segurança do usuário e do paciente. Isso inclui o software embutido nestes produtos. No Brasil, foi recentemente nacionalizada a ABNT NBR 62304:2023, que se preocupa com o ciclo de vida de software para os dispositivos médicos. Em contrapartida, o Brasil possui um programa de Melhoria do Processo de Software Brasileiro, o MPS.Br de Software, que também estipula Resultados Esperados que refletem uma boa qualidade no desenvolvimento. Também em 2023, o MPS.Br de Software foi atualizado. Assim, o problema de pesquisa abordado neste trabalho envolve “Como que o MPS.Br, por meio dos 4 processos de projeto de desenvolvimento de software é capaz de satisfazer as cláusulas da ABNT NBR 62304:2023?”. A solução proposta envolve a construção de um mapeamento focado inicialmente na atividade “Análise de Requisitos de Software” a ABNT NBR 62304:2023 para os Resultados Esperados do processo de Engenharia de Requisitos do MPS.Br de Software. Assim, os procedimentos metodológicos envolveram cinco etapas descritas neste trabalho envolvendo um grupo focal de especialistas neste domínio de software para dispositivos médicos. Promovendo um mapeamento das cláusulas envolvidas da ABNT NBR 62304:2023 para os Resultados Esperados do processo de Engenharia de Requisitos do MPS.Br de Software.Referências
ABNT (2023). Abnt nbr 62304:2023 software de dispositivo médico processo do ciclo de vida do software. Technical report, Associação Brasileira de Normas Técnicas.
Colenci Neto, A. and Cazarini, E. W. (2011). A referencial model for small companies of development software. IEEE Latin America Transactions, 9(1):89–95.
Ferreirós, A. (2015). Evaluation of accomplishment of do-178c objectives by cmmi-dev 1.3. Master’s thesis, Intituto Tecnológico de Aeronáutica (ITA).
ISO (2006). Iso/iec 62304:2006 medical device software software life-cycle processes. Technical report, International Electrotechnical Commission.
ISO (2015). Iso/iec 62304:2015 medical device software software life-cycle processes – amendment 1. Technical report, International Electrotechnical Commission.
ISO (2018). Iso/iec 29110:2018 systems and software engineering — lifecycle profiles for very small entities (vses). Technical report, International Standardization Organization.
ISO (2019). Iso 14971:2019 medical devices — application of risk management to medical devices. Technical report, International Standardization.
Kalinowski, M., Santos, G., Prikladnicki, R., Rocha, A. R., Weber, K. C., and Antonioni, J. A. (2011). From software engineering research to Brazilian software quality improvement. In Proceedings 25th Brazilian Symposium on Software Engineering, SBES 2011, pages 120–125.
Kasisopha, N. and Meananeatra, P. (2019). Applying iso/iec 29110 to iso/iec 62304 for medical device software sme. In Proceedings of the 2nd International Conference on Computing and Big Data, ICCBD 2019, page 121–125, New York, NY, USA. Association for Computing Machinery.
Machado, E. and Marques, J. (2023). Me-mps: An mr-mps-sw extension model for critical software in regulated environments. In Proceedings of the XXII Brazilian Symposium on Software Quality, SBQS ’23, page 52–61, New York, NY, USA. Association for Computing Machinery.
Magnuson, A. (2012). Iec/iso 62304 regulations for the development of medical software devices. Master’s thesis, Chalmers University of Technology.
Marques, J. (2019). Uma análise das características de especificação de requisitos de software em normas de ambientes regulados. In 22º Workshop de Engenharia de Requisitos (WER 2019).
Marques, J. and Cunha, A. (2019). Ares: An agile requirements specification process for regulated environments. International Journal of Software Engineering and Knowledge Engineering (IJSEKE), 29(10):1403–1438.
Marques, J., Yelisetty, S., and Barros, L. (2021). Um mapeamento sistemático da literatura no uso da iec 62304. Journal of Health Informatics.
Munch, J., Armbrunt, O., Kowalczyk, M., and Soto, M. (2012). Software Process Definition and Management. Springer-Verlag, Berlim, Germany.
Rocha, A., Oliveira, S., Souza, G., Brito, A., Santos, F., and Nunes, E. (2020). Mps appraisal online: An experience on covid-19 times. In Anais do XIX Simpósio Brasileiro de Qualidade de Software, pages 333–344, Porto Alegre, RS, Brasil. SBC.
RTCA (2011). Rtca do -178c software considerations in airborne systems and equipment certification. Technical report.
SEI (2010). Cmmi for development, version 1.3. Technical Report CMU/SEI-2010-TR033, Software Engineering Institute, Carnegie Mellon University, Pittsburgh, PA.
Softex (2023). Guia geral mps de software.
Colenci Neto, A. and Cazarini, E. W. (2011). A referencial model for small companies of development software. IEEE Latin America Transactions, 9(1):89–95.
Ferreirós, A. (2015). Evaluation of accomplishment of do-178c objectives by cmmi-dev 1.3. Master’s thesis, Intituto Tecnológico de Aeronáutica (ITA).
ISO (2006). Iso/iec 62304:2006 medical device software software life-cycle processes. Technical report, International Electrotechnical Commission.
ISO (2015). Iso/iec 62304:2015 medical device software software life-cycle processes – amendment 1. Technical report, International Electrotechnical Commission.
ISO (2018). Iso/iec 29110:2018 systems and software engineering — lifecycle profiles for very small entities (vses). Technical report, International Standardization Organization.
ISO (2019). Iso 14971:2019 medical devices — application of risk management to medical devices. Technical report, International Standardization.
Kalinowski, M., Santos, G., Prikladnicki, R., Rocha, A. R., Weber, K. C., and Antonioni, J. A. (2011). From software engineering research to Brazilian software quality improvement. In Proceedings 25th Brazilian Symposium on Software Engineering, SBES 2011, pages 120–125.
Kasisopha, N. and Meananeatra, P. (2019). Applying iso/iec 29110 to iso/iec 62304 for medical device software sme. In Proceedings of the 2nd International Conference on Computing and Big Data, ICCBD 2019, page 121–125, New York, NY, USA. Association for Computing Machinery.
Machado, E. and Marques, J. (2023). Me-mps: An mr-mps-sw extension model for critical software in regulated environments. In Proceedings of the XXII Brazilian Symposium on Software Quality, SBQS ’23, page 52–61, New York, NY, USA. Association for Computing Machinery.
Magnuson, A. (2012). Iec/iso 62304 regulations for the development of medical software devices. Master’s thesis, Chalmers University of Technology.
Marques, J. (2019). Uma análise das características de especificação de requisitos de software em normas de ambientes regulados. In 22º Workshop de Engenharia de Requisitos (WER 2019).
Marques, J. and Cunha, A. (2019). Ares: An agile requirements specification process for regulated environments. International Journal of Software Engineering and Knowledge Engineering (IJSEKE), 29(10):1403–1438.
Marques, J., Yelisetty, S., and Barros, L. (2021). Um mapeamento sistemático da literatura no uso da iec 62304. Journal of Health Informatics.
Munch, J., Armbrunt, O., Kowalczyk, M., and Soto, M. (2012). Software Process Definition and Management. Springer-Verlag, Berlim, Germany.
Rocha, A., Oliveira, S., Souza, G., Brito, A., Santos, F., and Nunes, E. (2020). Mps appraisal online: An experience on covid-19 times. In Anais do XIX Simpósio Brasileiro de Qualidade de Software, pages 333–344, Porto Alegre, RS, Brasil. SBC.
RTCA (2011). Rtca do -178c software considerations in airborne systems and equipment certification. Technical report.
SEI (2010). Cmmi for development, version 1.3. Technical Report CMU/SEI-2010-TR033, Software Engineering Institute, Carnegie Mellon University, Pittsburgh, PA.
Softex (2023). Guia geral mps de software.
Publicado
06/05/2024
Como Citar
MARQUES, Johnny; MACHADO, Everton.
Um Mapeamento do MPS.Br para o Desenvolvimento de Dispositivos Médicos com Foco em Engenharia de Requisitos. In: CONGRESSO IBERO-AMERICANO EM ENGENHARIA DE SOFTWARE (CIBSE), 27. , 2024, Curitiba/PR.
Anais [...].
Porto Alegre: Sociedade Brasileira de Computação,
2024
.
p. 241-255.
DOI: https://doi.org/10.5753/cibse.2024.28451.
