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首页> 外文会议>2017 IEEE/ACM 39th International Conference on Software Engineering: New Ideas and Emerging Technologies Results Track >DevOps in Regulated Software Development: Case Medical Devices
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DevOps in Regulated Software Development: Case Medical Devices

机译：规范软件开发中的DevOps：Case Medical Devices

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摘要

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.
机译：DevOps和持续开发在软件行业变得越来越流行。由于需要遵守法规，因此在法规环境（例如医疗设备软件）中采用这些现代方法并非易事。尽管DevOps依赖于连续部署和集成，但受监管的环境在发布之前需要严格的审核和批准。因此，与该主题的研究一样，很少在监管环境中使用现代开发方法。但是，随着软件在医疗设备中越来越占主导地位，现代软件开发方法变得越来越有吸引力。本文讨论了DevOps对规范医疗设备软件开发的适用性。对于使用DevOps进行医疗设备软件开发的障碍和好处，我们研究了两个相关标准IEC 62304和IEC 82304-1。我们发现这些标准为持续交付和集成设置了障碍。开发工具分别可以帮助满足这些标准的可追溯性和文档编制要求。

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