C-Scrum:用于数字健康的敏捷和自动化软件开发
Marius Gerdes1, Florian Mazura1, Rick Petzold1
1Karlsruhe Institute of Technology, Karlsruhe, Germany.
Studies in health technology and informatics
|May 17, 2025
概括
数字健康软件现在可以使用C-Scrum (Compliant-Scrum) 兼容和敏捷. 这种混合模式集成了风险分析和自动跟踪,以满足严格的认证要求,同时保留Scrum.
科学领域:
- 数字健康数字健康
- 软件工程 软件工程 软件工程
- 监管合规性 监管合规性
背景情况:
- 数字健康软件需要严格的认证流程.
- 传统的计划驱动开发通常与像Scrum这样的敏捷方法相冲突.
- 弥合合规和灵活性之间的差距对于数字健康创新至关重要.
研究的目的:
- 为了引入C-Scrum (符合Scrum),一个新的混合模型.
- 为了使严格的认证要求与Scrum的敏捷原则相协调.
- 增强符合数字健康软件的开发过程.
主要方法:
- 开发了C-Scrum,这是一个混合敏捷框架.
- 将基于特征的风险分析纳入开发生命周期.
- 集成的自动化合规跟踪机制.
- 杆式持续整合和持续部署 (CI/CD) 管道.
主要成果:
- C-Scrum有效地弥合了合规性和敏捷性之间的差距.
- 该模型展示了直观的设计和实际的可行性.
- 专家评估验证了该框架能够保持监管遵守和开发灵活性的能力.
- 成功整合风险分析,自动跟踪和CI/CD.
结论:
- C-Scrum为开发符合标准的数字健康软件提供了一个可行的解决方案.
- 混合型号支持严格的认证要求和敏捷的适应性.
- 在数字健康领域,C-Scrum促进了高效和合规的软件开发.
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