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Software of Unknown Provenance, SOUP, refers to a software component that isalready developed and widely available from a 3rd party, and that has not beendeveloped, to be integrated into a medical device. From regulatory perspective,SOUP software requires special considerations, as the developers' obligationsrelated to design and implementation are not applied to it. In this paper, weconsider the implications of extending the concept of SOUP to machine learning(ML) models. As the contribution, we propose practical means to manage theadded complexity of 3rd party ML models in regulated development.

Extending SOUP to ML Models When DesigningCertified Medical Systems