Paper Info
Title
DevOps in Regulated Software Development: Case Medical Devices.
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.
Year
DOI
Venue
2017
10.1109/ICSE-NIER.2017.20
ICSE-NIER
Keywords
Field
DocType
Regulated software, agile development, DevOps, medical software development standards
Continuous delivery,Medical software,IEC 62304,Systems engineering,Software engineering,Computer science,Release management,Agile software development,DevOps,Software development process,Software development
Conference
ISBN
Citations 
PageRank 
978-1-5386-2676-4
5
0.68
References 
Authors
7
3
Name
Order
Citations
PageRank
Teemu Laukkarinen1366.56
Kati Kuusinen27512.66
Tommi Mikkonen3788122.54