软件驱动医疗技术的成熟度评估:从研究阶段的质量标准中得出的定量得分
概括
本研究引入了软件成熟度评分,用于在研究期间评估软件驱动医学技术 (SdMT). 这种定量评估有助于改善从研究到工业的技术转让.
科学领域:
- 医疗器械工程 医疗器械工程
- 软件工程 软件工程 软件工程
- 技术转让 技术转让 技术转让
背景情况:
- 评估医疗技术准备程度对于成功的研究向行业转移至关重要.
- 创新的医疗器械往往包含软件,需要特定的评估方法.
- 目前在早期医疗技术中评估软件成熟度的方法有限.
研究的目的:
- 提出一种方法来评估软件驱动医疗技术 (SdMT) 在研究阶段的软件成熟度.
- 为SdMT.开发一个定量软件成熟度评分.
- 帮助利益相关者识别和改善技术准备用于临床研究和转移.
主要方法:
- 通过从ISO/IEC 62304标准中提取术语,开发了一个技术成熟度模型.
- 创建了所需软件工程文物及其相对权重的列表.
- 为SdMT建立了一个软件成熟度评分和评估问卷.
主要成果:
- 开发了一种一致的模型来评估SDMT软件成熟度.
- 软件成熟度得分是可量化的,取决于软件工程工件的存在和重要性.
- 该模型的一致性根据ISO/IEC 62304标准进行了验证.
结论:
- 拟议的定量成熟度评分为评估研究阶段的SdMT准备提供了有价值的工具.
- 这一分数可以显著帮助临床医生,研究人员和行业专业人士.
- 该方法促进了医疗创新技术转让的改进识别,增强和加速.
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