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Continuous software engineering has become commonplace in numerous fields.However, in regulating intensive sectors, where additional concerns needs to betaken into account, it is often considered difficult to apply continuousdevelopment approaches, such as devops. In this paper, we present an approachfor using pull requests as design controls, and apply this approach to machinelearning in certified medical systems leveraging model cards, a novel techniquedeveloped to add explainability to machine learning systems, as a regulatoryaudit trail. The approach is demonstrated with an industrial system that wehave used previously to show how medical systems can be developed in acontinuous fashion.

Continuous Design Control for Machine Learning in Certified Medical Systems