Tampere University of Technology

TUTCRIS Research Portal

DevOps in regulated software development: Case medical devices

Research output: Chapter in Book/Report/Conference proceedingConference contributionScientificpeer-review

Details

Original languageEnglish
Title of host publicationProceedings - 2017 IEEE/ACM 39th International Conference on Software Engineering: New Ideas and Emerging Results Track, ICSE-NIER 2017
PublisherIEEE
Pages15-18
Number of pages4
ISBN (Electronic)9781538626757
DOIs
Publication statusPublished - 30 Jun 2017
Publication typeA4 Article in a conference publication
EventIEEE/ACM INTERNATIONAL CONFERENCE ON SOFTWARE ENGINEERING -
Duration: 1 Jan 1900 → …

Conference

ConferenceIEEE/ACM INTERNATIONAL CONFERENCE ON SOFTWARE ENGINEERING
Period1/01/00 → …

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.

Keywords

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

Publication forum classification

Field of science, Statistics Finland