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近年来,医疗器械产业的飞速发展,医疗器械软件的应用越来越广泛,起到了关键甚至核心的作用,而同时软件错误造成严重后果的情况也越来越突出。经统计,美国FDA公布的数据,1999~2005年期间,共有3771个产品被召回,由于软件故障被召回的产品有425个,占全部被召回产品的11.3%。什么是医疗器械软件?与常规医疗器械相比有哪些特点?如何保障其质量安全?笔者结合日常工作就此进行分析。医疗器械软件应用广泛根据医药行业标准YY/T0664-2008
In recent years, with the rapid development of medical device industry, the application of medical device software is more and more widely, which plays a key and even core role. At the same time, the serious consequences of software errors are becoming more and more prominent. According to statistics, a total of 3,771 products were recalled during the period from 1999 to 2005 according to the data released by the U.S. FDA. There were 425 recalled products due to software failures, accounting for 11.3% of the total recalled products. What is the medical device software? What are the characteristics compared with the conventional medical device? How to protect the quality and safety? The author combines the routine work to do this analysis. Medical device software is widely used according to the pharmaceutical industry standard YY / T0664-2008