Towards Regulatory-Compliant MLOps: Oravizio’s Journey from a Machine Learning Experiment to a Deployed Certified Medical Product

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Extending SOUP to ML Models in Certified Medical Systems

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MLOps Challenges in Multi-Organization Setup: Experiences from Two Real-World Cases

Workshop on AI Engineering - Software Engineering for AI , WAIN ; Conference date: 30-05-2021 Through 31-05-2021Peer reviewe

On Medical Device Cybersecurity Compliance in EU

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Continuous design control for machine learning in certified medical systems

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.Peer reviewe