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  1. Proceedings of the 39th International Conference on Software Engineering (ICSE-NIER '17)
  2. DevOps in regulated software development: case medical devices
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Mutation testing meets approximate computing
At the end of synthesis: narrowing program candidates
On accelerating ultra-large-scale mining
Performance metamorphic testing: motivation and challenges
Production-driven patch generation
Building usage profiles using deep neural nets
Anger and its direction in collaborative software development
Statistical learning for inference between implementations and documentation
DARVIZ: deep abstract representation, visualization, and verification of deep learning models
DevOps in regulated software development: case medical devices
GuideAutomator: continuous delivery of end user documentation
The impact of retrieval direction on IR-based traceability link recovery
Accelerating software engineering research adoption with analysis bots
In the field monitoring of interactive applications

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DevOps in regulated software development: case medical devices

Content Provider ACM Digital Library
Author Mikkonen, Tommi Kuusinen, Kati Laukkarinen, Teemu
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.
Starting Page 15
Ending Page 18
Page Count 4
File Format PDF
ISBN 9781538626757
DOI 10.1109/ICSE-NIER.2017.20
Language English
Publisher Association for Computing Machinery (ACM)
Publisher Date 2017-05-20
Access Restriction Subscribed
Subject Keyword Regulated software Agile development Medical software development standards Devops
Content Type Text
Resource Type Article
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