0000000000878658
AUTHOR
Vlad Stirbu
Continuous design control for machine learning in certified medical systems
AbstractContinuous 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 con…
Introducing Traceability in GitHub for Medical Software Development
Assuring traceability from requirements to implementation is a key element when developing safety critical software systems. Traditionally, this traceability is ensured by a waterfall-like process, where phases follow each other, and tracing between different phases can be managed. However, new software development paradigms, such as continuous software engineering and DevOps, which encourage a steady stream of new features, committed by developers in a seemingly uncontrolled fashion in terms of former phasing, challenge this view. In this paper, we introduce our approach that adds traceability capabilities to GitHub, so that the developers can act like they normally do in GitHub context bu…
Towards multi-concern software development with Everything-as-Code
As software is becoming a central element in our lives, more and more stakeholders have concerns. Unlike today, when developers stop their coding activities to satisfy these stakeholder concerns, we propose dealing with them as part of the coding workflow, the central element of programmers’ daily duties. This can be achieved by extending the approach that we call Everything-as-Code (EaC) beyond software engineers and operators. peerReviewed
Medical Software Needs Calm Compliance
The promise of calm computing, a concept introduced by Mark Weiser more than 20 years ago, has been mostly realized today. For instance, as an end user, you expect to interact during your daily routine with a multitude of sophisticated services and applications without being aware of their technical implementation. All you need is a smartphone and an always-on Internet connection. peerReviewed