A Mapping of MPS.Br for the Development of Medical Devices with a Focus on Requirements Engineering
Abstract
All Medical Devices must comply with regulations to ensure user and patient safety. This includes the embedded software in these products. In Brazil, the ABNT NBR 62304:2023 was recently nationalized, focusing on the software lifecycle for medical devices. Conversely, Brazil has a Brazilian Software Process Improvement Program, MPS.Br for Software, which also sets Expected Outcomes reflecting good quality in development. Also in 2023, MPS.Br for Software was updated. Therefore, the research problem addressed in this work involves “How does MPS.Br, through the 4 software development design processes, manage to meet the clauses of ABNT NBR 62304:2023?” The proposed solution involves constructing a mapping initially focused on the ”Software Requirements Analysis”activity of ABNT NBR 62304:2023 to the Expected Outcomes of the Software Requirements Engineering process of MPS.Br for Software. Thus, the methodological procedures involved five stages described in this work, including a focus group of experts in this software domain for medical devices. Promoting mapping of the clauses involved in ABNT NBR 62304:2023 to the Outcomes of the Software Requirements Engineering process of MPS.Br for Software.References
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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.
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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.
Published
2024-05-06
How to Cite
MARQUES, Johnny; MACHADO, Everton.
A Mapping of MPS.Br for the Development of Medical Devices with a Focus on Requirements Engineering. In: IBERO-AMERICAN CONFERENCE ON SOFTWARE ENGINEERING (CIBSE), 27. , 2024, Curitiba/PR.
Anais [...].
Porto Alegre: Sociedade Brasileira de Computação,
2024
.
p. 241-255.
