A1 Journal article (refereed)
Continuous design control for machine learning in certified medical systems (2023)
Stirbu, V., Granlund, T., & Mikkonen, T. (2023). Continuous design control for machine learning in certified medical systems. Software Quality Journal, 31, 307-333. https://doi.org/10.1007/s11219-022-09601-5
JYU authors or editors
Publication details
All authors or editors: Stirbu, Vlad; Granlund, Tuomas; Mikkonen, Tommi
Journal or series: Software Quality Journal
ISSN: 0963-9314
eISSN: 1573-1367
Publication year: 2023
Publication date: 17/10/2022
Volume: 31
Pages range: 307-333
Publisher: Springer
Publication country: United States
Publication language: English
DOI: https://doi.org/10.1007/s11219-022-09601-5
Publication open access: Openly available
Publication channel open access: Partially open access channel
Publication is parallel published (JYX): https://jyx.jyu.fi/handle/123456789/83593
Web address of parallel published publication (pre-print): https://arxiv.org/abs/2209.05843
Abstract
Continuous software engineering has become commonplace in numerous fields. However, in regulating intensive sectors, where additional concerns need to be taken into account, it is often considered difficult to apply continuous development approaches, such as devops. In this paper, we present an approach for using pull requests as design controls, and apply this approach to machine learning in certified medical systems leveraging model cards, a novel technique developed to add explainability to machine learning systems, as a regulatory audit trail. The approach is demonstrated with an industrial system that we have used previously to show how medical systems can be developed in a continuous fashion.
Keywords: machine learning; planning and design; medical technology; computer programmes; engineering design; software design
Free keywords: machine learning; design control; medical software; regulated software; continuous engineering
Contributing organizations
Ministry reporting: Yes
Reporting Year: 2022
JUFO rating: 2
