Continuous software engineering has become commonplace in numerous fields. However, in regulating intensive sectors, where additional concerns needs 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.

翻译：连续软件工程在许多领域已司空见惯,然而,在监管需要考虑更多关切的密集部门时,往往认为难以采用持续开发方法,如发布软件等。 在本文中,我们提出将拉动请求用作设计控制的方法,并将这一方法用于在认证的医疗系统中的机器学习,利用模型卡,这是为向机器学习系统增加解释性而开发的一种新技术,作为监管审计线索。 这种方法通过我们以前用来说明如何持续开发医疗系统的工业系统来证明。