QSR 820设计开发输入的内容理解

戊戌

请教下各位老师，QSR 820中，820.30（c）设计输入，

Design input. Each manufacturer shall establish and maintain procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient. The procedures shall include a mechanism for addressing incomplete, ambiguous, or conflicting requirements. The design input requirements shall be documented and shall be reviewed and approved by a designated individual(s). The approval, including the date and signature of the individual(s) approving the requirements, shall be documented.
各制造商应建立并保持程序，保证器械的设计要求是适当的，阐明器械的预期用途，包括使用者和病人需要。该程序应包括指出不完善的、含糊不清的或矛盾要求的机制。设计输入要求应形成文件，由指定人员评审和批准。批准，包括批准人的签字和日期应文件化。


其中，这段话中，“The procedures shall include a mechanism for addressing incomplete, ambiguous, or conflicting requirements该程序应包括指出不完善的、含糊不清的或矛盾要求的机制。”这句话怎么理解，可以的话帮忙举个例子辅助讲解。


谢谢各位老师。

淡大芸1

楼主，有最新中文翻译版吗

戊戌

仅供参考哈