摘要
根据国际标准ISO14971及欧盟医疗器械法令93/42/EEC的有关要求,着重介绍了售后监督活动在医疗器械产品中的应用现状、实施重点和发展趋势,结合医疗器械生产企业对售后监督的实践经验,为医疗器械生产企业如何理解、实施售后监督提出了方法和建议。
Based on the practices of the post-market surveillance activities by Medical Device Manufacturer and theoretical study of the latest international standard ISO 14971 and European Medical Device Directives 93/42/EEC, this article analyses the post-market surveillance activities in Medical Device Manufacturer by introducing the status quo of applications, implementation emphasis and further trends of development, methods and suggestions are therefore given to implant medical device manufacturer for postmarket surveillance.
出处
《中国医疗器械信息》
2013年第1期44-47,60,共5页
China Medical Device Information
关键词
售后监督售后临床跟踪
医疗器械
post-market surveillance, post market clinical follow up, medical device
