Software quality in medical devices-a top-down approach

[1993] Computer-Based Medical Systems-Proceedings of the Sixth Annual IEEE Symposium Pub Date : 1993-06-13 DOI:10.1109/CBMS.1993.263001

Dean A. Leffingwell, B. Norman

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引用次数: 4

Abstract

The development of highly reliable software is key to the success of many of today's medical devices and instruments. The development of such software is achieved through a phased development process that starts with requirements and ends when the product reaches the market. Quality medical software is achieved by applying verification and validation techniques throughout he different development phases. Verification and validation (V&V) has successfully been applied to software in military, aerospace, and medical systems. Because applied V&V yields highly reliable software in the demanding medical environment, verification and validation techniques represent the leading edge in achieving solid medical software quality. V&V is a proven method for producing quality software. Verification assures that each time a step is taken in the software development process, testing is performed to ensure that the step was done correctly. Validation compares the final product to the original specification. A software-controlled device that does not perform as expected may be acceptable in some industries. In the medical device field, defect-ridden software could prove to be fatal.<>

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医疗设备中的软件质量——自上而下的方法

高度可靠的软件的开发是当今许多医疗设备和仪器成功的关键。这种软件的开发是通过一个分阶段的开发过程来实现的，这个开发过程从需求开始，到产品进入市场时结束。高质量的医疗软件是通过在不同的开发阶段应用验证和确认技术来实现的。验证和确认(V&V)已成功应用于军事、航空航天和医疗系统的软件中。由于应用V&V在要求苛刻的医疗环境中产生高度可靠的软件，验证和验证技术代表了实现可靠医疗软件质量的领先优势。V&V是生产高质量软件的一种行之有效的方法。验证确保每次在软件开发过程中采取一个步骤时，都要执行测试以确保正确地完成该步骤。验证将最终产品与原始规范进行比较。在某些行业中，软件控制的设备不能按预期运行是可以接受的。在医疗设备领域，充满缺陷的软件可能是致命的。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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[1993] Computer-Based Medical Systems-Proceedings of the Sixth Annual IEEE Symposium

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