应用和验证内部开发的医疗软件的质量管理系统
Vera Lagerburg1,2, Michelle van den Boorn3, Reinier F Crane3
1Department of Medical Physics, OLVG, Amsterdam, Netherlands.
Frontiers in digital health
|April 16, 2025
概括
根据"医疗器械条例" (MDR) 实施内部医疗软件开发的质量管理系统 (QMS) 是可行的. 现有的数据科学程序可以适应以最小的努力满足MDR要求,确保监管合规.
科学领域:
- 医疗器械规则 医疗器械规则
- 软件工程 软件工程 软件工程
- 质量管理系统 质量管理系统
背景情况:
- 2021年推出的医疗器械条例 (MDR) 大大改变了公司内部医疗器械开发立法.
- 对于内部医疗软件的质量管理系统 (QMS) 实施的实际指南是有限的.
研究的目的:
- 描述满足MDR要求的体验,用于内部开发的预测模型,被归类为医疗软件.
- 证明医疗软件现有质量管理体系框架的适应性.
主要方法:
- 基于ISO13485:2016的QMS被实施,整合了现有的数据科学团队程序.
- 通过文档和格式标准化,确定了当前软件开发实践和质量管理系统要求之间的差距并加以解决.
主要成果:
- 19%的质量管理系统元素不适用于软件开发项目.
- 对于适用的元素,32%不需要额外的文档,23%需要补充信息,45%需要使用标准的QMS格式.
结论:
- 设计用于物理医疗设备的QMS可以适应医疗软件的MDR.
- 成功的适应需要最小的努力,当一个结构化的软件开发方法已经到位.
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