6533b821fe1ef96bd127c2da
RESEARCH PRODUCT
Continuous design control for machine learning in certified medical systems
Vlad StirbuTuomas GranlundTommi Mikkonensubject
FOS: Computer and information scienceslääketieteellinen tekniikkaComputer Science - Artificial Intelligencetekninen suunnittelutietokoneohjelmat113 Computer and information sciencesregulated softwarecontinuous engineeringSoftware Engineering (cs.SE)ohjelmistosuunnittelusuunnitteluComputer Science - Software EngineeringArtificial Intelligence (cs.AI)machine learningkoneoppiminenmedical softwaredesign controlSafety Risk Reliability and QualitySoftwaredescription
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 continuous fashion.
| year | journal | country | edition | language |
|---|---|---|---|---|
| 2022-01-01 | Software Quality Journal |