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Computer Science > Software Engineering

arXiv:2103.09510 (cs)
[Submitted on 17 Mar 2021]

Title:Extending SOUP to ML Models When DesigningCertified Medical Systems

Authors:Vlad Stirbu, Tuomas Granlund, Jere Helén, Tommi Mikkonen
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Abstract:Software of Unknown Provenance, SOUP, refers to a software component that is already developed and widely available from a 3rd party, and that has not been developed, to be integrated into a medical device. From regulatory perspective, SOUP software requires special considerations, as the developers' obligations related to design and implementation are not applied to it. In this paper, we consider the implications of extending the concept of SOUP to machine learning (ML) models. As the contribution, we propose practical means to manage the added complexity of 3rd party ML models in regulated development.
Subjects: Software Engineering (cs.SE)
Cite as: arXiv:2103.09510 [cs.SE]
  (or arXiv:2103.09510v1 [cs.SE] for this version)
  https://doi.org/10.48550/arXiv.2103.09510
Related DOI: https://doi.org/10.1109/SEH52539.2021.00013

Submission history

From: Vlad Stirbu [view email]
[v1] Wed, 17 Mar 2021 09:00:02 UTC (1,145 KB)
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