软件验证
Software validation.
作者信息
Wenner H
机构信息
EUROSPEC GmbH, Darmstadt, Germany.
出版信息
Med Device Technol. 1997 Apr;8(3):22-5.
PMID:10167683
Abstract
This article examines the requirements of EN 60601-1-4, which states that risk management is an integral part of the development of software for medical devices. Food and Drug Administration regulations are also compared to the requirements of the Medical Device Directive to provide guidance on developing software for the European and US markets.
摘要
本文探讨了EN 60601-1-4的要求，该标准指出风险管理是医疗设备软件开发过程中不可或缺的一部分。同时还将美国食品药品监督管理局的法规与《医疗器械指令》的要求进行了比较，以为欧洲和美国市场的软件开发提供指导。
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