如何更好地系统地满足医疗软件的质量要求?

Karin Messer-Misak, J. D. Bruin, S. Hanke
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引用次数: 0

摘要

由于各种因素,其中包括医疗和立法要求,对医疗软件的质量要求越来越高。一些质量标准和指导方针已经到位,例如ISO/IEC s9126, 14598和25000 (SQaRE)。然而,对于这些标准是否对医疗软件不够具体,存在争议。此外,它们在需求收集、分析和监视方面的有效应用可能是困难的。本文提出了一个应用ISO/IEC 25010:2011标准的工作流程,系统地收集、分析和评估各利益相关方的需求,以便系统地更好地满足医疗软件的质量要求
本文章由计算机程序翻译,如有差异,请以英文原文为准。
HOW CAN QUALITY REQUIREMENTS FOR MEDICAL SOFTWARE BE SYSTEMATICALLY FULFILLED BETTER?
Due to a variety of factors, among others medical and legislative requirements, the quality requirements on medical software become increasingly demanding. Several quality standards and guidelines are already in place, e.g., ISO/IEC s9126, 14598 and 25000 (SQaRE). However, there is a debate on whether these standards are not specific enough for medical software. Furthermore, their effective application for requirement gathering, analysis and monitoring can be difficult. In this paper, we propose a workflow for the application of the ISO/IEC 25010:2011 standard for the systematic collection, analysis and evaluation of requirements for various stakeholders in order to systematically better fulfill quality requirements on medical software
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