协助医疗器械法规的培训。
随着医疗器械法规的不断完善，国家对医疗器械的使用监督管理越来越严格。
Along the rule of medical instrument is more perfect, it is stricter to monitor and manage medical instrument in our country.
应对这些投诉进行评估，并根据医疗器械报告制度(联邦法规21篇804或803部)要求决定它们是否需要向FDA报告。
These complaints shall be evaluated to determine whether or not they require reporting to FDA under 21 CFR part 804 or 803, Medical Device reporting.
组织应当确定医疗器械的功能、操作、可用性、安全性和适当的法规要求和它的预期用途变更的重要性。
The organization shall determine the significance of the change to function, performance, usability, safety and applicable regulatory requirements for the medical device and its intended use.
质量体系法规描述设计和生产医疗器械最少体系要素。
The Quality System regulation outlines the minimum elements of a system for designing and producing a medical device.
除非获得有效的豁免批准，QS法规适用于以销售为目的的人用医疗器械制成品。
The QS regulation applies to finished devices intended to be commercially distributed for human use unless there is an approved exemption in effect.
因而，质量体系法规帮助确保医疗器械对其目的应用安全有效。
Thus, the QS regulation helps assure that medical devices are safe and effective for their intended use.
文章探究了我国医疗器械风险管理的现状、不同责任主体的职责，并简要介绍了相关法规。
This paper analyses the status quo of risk management in medical device include the responsibility of different body duty and relevant regulation.
顺应QS法规确保制造流程可以持续达到期望的质量水平，并使医疗器械达到其设计主文件规格要求。
Complying with the QS regulation assures that the manufacturing processes can consistently achieve desired levels of quality and that the finished device meets its device master record specifications.
本文通过介绍法规变化背景，分析法规变化特点，指出了我国医疗器械监管工作今后的发展趋势和医疗器械企业的应对措施。
The paper introduces the background of regulations' amending and analyzes characteristic, points out the trend in administrating work's future and response measure of medical device enterprises.
随后论文第二章是关于医疗器械标准的分类、技术法规、自愿标准、医疗器械国际标准制定组织等标准相关的基础内容。
S. , Europe and China. The second chapter is about the classification of medical device standards, technical regulation, voluntary standards, international standards organization.
随后论文第二章是关于医疗器械标准的分类、技术法规、自愿标准、医疗器械国际标准制定组织等标准相关的基础内容。
S. , Europe and China. The second chapter is about the classification of medical device standards, technical regulation, voluntary standards, international standards organization.
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