在有源医疗器械领域，越来越多的产品功能都通过软件来灵活实现，因此，由于软件缺陷引发的医疗事故也越来越多。FDA历年的医疗器械召回数据也表明，由于软件缺陷引发的召回数量呈显著的增长趋势。如何提高医疗器械厂商生产高可靠性医疗器械软件的能力成为当前工程界面临的重大难题。论文从传统计算机科学领域的软件可靠性研究成果出发，针对医疗器械软件自身的特点，遵循监管部门对医疗器械软件上市前的审查要求，探索了适合我国行业现状的医疗器械软件可靠性保证方案，并在实际的工程项目中得到了成功的应用，对我国医疗器械行业生产高可靠性软件产品起到积极的促进作用。论文首先针对FDA的医疗器械软件监管要求进行深入调研，发现其主要的思想在于基于不同风险关注等级的软件监管要求和对软件开发过程的严格控制。然而，由于FDA监管的初衷是希望投放市场的产品尽可能可靠、安全，因此其所提要求在工程实践中往往显得过于严格；并且其指南文件也没有对医疗器械厂商做出明确的工作指导，厂商在执行指南文件的要求时就像是在做选择题，这对于规范市场尤其是不成熟的市场的生产行为是较为不利的。紧接着，论文分析了我国最新医疗器械软件监管要求，并与FDA的要求进行对比，在明确监管方向之后，探索了基于软件工程思想的医疗器械软件可靠性保证方案。包括软件开发过程、软件维护过程、软件风险管理过程、软件配置管理过程和软件问题解决过程在内的五大生存周期过程。整个方案的制定过程中，充分借鉴了我国921工程软件工程化的实践经验，把重点集中在面向工程和方案的可操作性上。最后，论文对软件开发过程中非常重要的软件验证活动进行了进一步的研究。软件自动测试技术作为提高软件测试效率和测试可靠性的有效手段并未广泛应用于系统验证活动中，因为系统验证往往需要产品硬件的支持，而不同医疗器械产品的硬件功能和接口千差万别。论文利用软件模块设计技术，设计了具有一定通用性的自动测试系统，在一定的使用范围内可以有效的解决这一问题，进一步提高最终软件产品的可靠性。
More and more medical device features can be achieved by the flexible software designs in the field of active medical device, and the quantity of medical accidents caused by software failures is growing rapidly, which has been proved clearly by the recall data of medical devices from FDA. As a result, to improve the ability of medical equipment manufacturers of producing high reliability medical device software is the major problem faced by the experts.Based on the software reliability research of the traditional computer science field and the review requirements prior to the market from the regulatory authorities, this article explored a software reliability assurance scheme suiting for the medical device software industry status in the country. Furthermore, an applying attempt of the scheme during an actual project was implemented successfully. The effort will play a positive role in promoting the ability of producing high reliability medical device software of China’s medical equipment industry.There are two major issues of the FDA’s regulatory requirements of the medical device software. The first one is the regulatory requirements based on different risk level of concern, and the other is the strict control of the software development process. Since the objective of the FDA’s regulatory is only to ensure the reliability and safety of the products to market, the requirements always seem to be too strict in engineering practice. Also, the guidance documents of the FDA have no clear operational instructions for the manufacturers. As a result, the manufacturers become more confused during the practices, and the efforts of regulating the production of the market, especially the immature market, are more difficulty.On this basis, an analysis on the latest regulatory requirements of the medical device software of SFDA was carried out. After the comparison with the FDA’s requirements, a software reliability assurance scheme based on the software engineering concepts was provided, which include the software development process, software maintenance process, software risk management process, software configuration management and software problem solving process. The software engineering experience of manned space engineering was widely used in the scheme, which advised to pay more attention to the operability of the engineering.A further study on the software verification activities of the software development process was also implemented. The software automatic testing technology, which can significantly improve the efficiency and reliability of test, has not been widely used in system validation activities, for the reason that the system validation often involves the product hardware, which always have great difference between each other. However, software modular design technology can be used to design an automatic test system with certain versatility within a certain range, which can be used to further improve the reliability of the final software product.
