论文标题

ISO 13485受监管环境中的DevOps:多局文献综述

DevOps in an ISO 13485 Regulated Environment: A Multivocal Literature Review

论文作者

Lie, Martin Forsberg, Sánchez-Gordón, Mary, Colomo-Palacios, Ricardo

论文摘要

背景:医疗设备开发项目必须遵循适当的指令和法规,以便能够在各自领土上销售和销售最终产品。该法规描述了似乎与有效的软件开发和短暂出售时间相反的要求。随着敏捷方法(如DevOps)在软件行业中变得越来越流行,这些现代方法与传统监管发展之间的差异。尽管存在这种情况下成功采用的例子,但研究很少。目的:这项研究的目的是双重的:回顾受管制的医疗设备环境中DevOps采用的现状;并根据该评论提出一个清单,以在这种情况下介绍DevOps。方法:进行了多局文献综述,并从2015年至2020年3月之间发布的来源合成了证据,以捕获该领域的专家和社区的意见。结果:我们的发现表明,在ISO 13485等受管制的医疗设备环境中采用DEVOPS的挑战,但潜在的好处可能超过了在法规,合规性,安全性,安全性,组织和技术的领域中的挑战。结论:与传统方法相比,受管制的医疗设备环境的DevOps是一种高度吸引人的方法,可能特别适合受监管的医学发展。但是,组织必须适当地将过渡到高层管理中的Devops,并在初始阶段使用专业教练和空间进行迭代学习;因此,一项倡议是一项复杂的组织和技术任务。

Background: Medical device development projects must follow proper directives and regulations to be able to market and sell the end-product in their respective territories. The regulations describe requirements that seem to be opposite to efficient software development and short time-to-market. As agile approaches, like DevOps, are becoming more and more popular in software industry, a discrepancy between these modern methods and traditional regulated development has been reported. Although examples of successful adoption in this context exist, the research is sparse. Aims: The objective of this study is twofold: to review the current state of DevOps adoption in regulated medical device environment; and to propose a checklist based on that review for introducing DevOps in that context. Method: A multivocal literature review is performed and evidence is synthesized from sources published between 2015 to March of 2020 to capture the opinions of experts and community in this field. Results: Our findings reveal that adoption of DevOps in a regulated medical device environment such as ISO 13485 has its challenges, but potential benefits may outweigh those in areas such as regulatory, compliance, security, organizational and technical. Conclusion: DevOps for regulated medical device environments is a highly appealing approach as compared to traditional methods and could be particularly suited for regulated medical development. However, an organization must properly anchor a transition to DevOps in top-level management and be supportive in the initial phase utilizing professional coaching and space for iterative learning; as such an initiative is a complex organizational and technical task.

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