DevOps in regulated software development: case medical devices

Teemu Laukkarinen, Kati Kuusinen, Tommi Mikkonen

Research output: Chapter in Book/Report/Conference proceedingArticle in proceedingsResearchpeer-review

Abstract

DevOps and continuous development are getting popular in the software industry. Adopting these modern approaches in regulatory environments, such as medical device software, is not straightforward because of the demand for regulatory compliance. While DevOps relies on continuous deployment and integration, regulated environments require strict audits and approvals before releases. Therefore, the use of modern development approaches in regulatory environments is rare, as is the research on the topic. However, as software is more and more predominant in medical devices, modern software development approaches become attractive. This paper discusses the fit of DevOps for regulated medical device software development. We examine two related standards, IEC 62304 and IEC 82304-1, for obstacles and benefits of using DevOps for medical device software development. We found these standards to set obstacles for continuous delivery and integration. Respectively, development tools can help fulfilling the requirements of traceability and documentation of these standards.
Original languageEnglish
Title of host publication2017 IEEE/ACM 39th International Conference on Software Engineering: New Ideas and Emerging Technologies Results Track (ICSE-NIER)
PublisherIEEE
Publication date2017
Pages15-18
ISBN (Print)978-1-5386-2676-4
ISBN (Electronic)978-1-5386-2675-7
DOIs
Publication statusPublished - 2017
Externally publishedYes
Event2017 IEEE/ACM 39th International Conference on Software Engineering: New Ideas and Emerging Technologies Results Track (ICSE-NIER) - Buenos Aires, Argentina
Duration: 20. May 201728. May 2017

Conference

Conference2017 IEEE/ACM 39th International Conference on Software Engineering
Country/TerritoryArgentina
CityBuenos Aires
Period20/05/201728/05/2017

Keywords

  • DevOps
  • Regulated software
  • agile development
  • medical software development standards

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