Introducing Traceability in GitHub for Medical Software Development

@article{Stirbu2021IntroducingTI,
  title={Introducing Traceability in GitHub for Medical Software Development},
  author={Vlad Stirbu and Tommi Mikkonen},
  journal={ArXiv},
  year={2021},
  volume={abs/2110.13034}
}
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… 

References

SHOWING 1-10 OF 16 REFERENCES
DevOps in practice: A multiple case study of five companies
CompliancePal: A Tool for Supporting Practical Agile and Regulatory-Compliant Development of Medical Software
  • Vlad Stirbu, T. Mikkonen
  • Computer Science
    2020 IEEE International Conference on Software Architecture Companion (ICSA-C)
  • 2020
TLDR
The implementation of a service that integrates medical device software compliance specific activities such as architectural design and limited risk management into the daily agile practices of a software development team is described.
Towards Automated Evidence Generation for Rapid and Continuous Software Certification
TLDR
SHERLOCK is described, an integrated environment to facilitate the rapid and continuous certification of software systems using the novel concept of Traceability Certification Models (TCM) and a Catalog of Certification Assurance Case Patterns (CACP) which guides the efforts of establishing the required trace links for fulfilling the criteria for a given certification.
ISO 13485:2016
[siteorigin_widget class=SiteOrigin_Widget_Image_Widget][/siteorigin_widget] ISO 13485:2016 szabvany az orvostechnikai eszkozoket gyarto es ...
ISO 14971:2019
  • Medical devices – Application of risk management to medical devices
  • 2019
International Organization for Standardization: ISO 14971:2019. Medical devices -Application of risk management to medical devices
  • 2019
Continuous software engineering: A roadmap and agenda
DevOps in Regulated Software Development: Case Medical Devices
TLDR
This paper examines two related standards, IEC 62304 and IEC 82304-1, for obstacles and benefits of using DevOps for medical device software development, and found these standards to set obstacles for continuous delivery and integration.
IEC 82304-1:2016
  • Health software – Part 1: General requirements for product safety
  • 2016
International Electrotechnical Commission: IEC 82304-1:2016. Health software -Part 1: General requirements for product safety
  • 2016
...
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