这项由行业贸易刊物《质量体系法规》委托开展的研究显示，这比行业平均水平多出了约10秒，而且比10年前慢了很多。
That's about ten seconds more than the industry average—and a lot slower than a decade ago, according to the study, which was commissioned by QSR, an industry trade publication.
在本手册的附录中重印了质量体系法规。
The QS regulation is reprinted in the appendix of this manual.
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.
因而导言内容包含了质量体系法规目的意义的真知灼见。
Thus, the preamble contains valuable insight into the meaning and intent of the QS regulation.
本手册会帮助你建立满足FDA质量体系法规意图的质量系统。
This manual will assist you in developing a quality system that meets the intent of the FDA Quality System regulation.
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.
导言描述在建立本质量体系法规时收到的公众评论，及FDA专员对这些评论的解答。
The preamble describes the public comments received during the development of the QS regulation and describes the FDA Commissioner's resolution of the comments.
这样，再装箱者、再包装者或再标识者都是制造商，均应遵守质量体系法规中适用的要求。
Further, a repacker, repackager or relabeler is a manufacturer per 820.3(o) and subject to the applicable requirements of the QS regulation.
然而，在有些情况下，质量体系法规确实规定采用某种方法，诸如书面的步骤或书面的指令。
In some cases, however, the QS regulation does specify the particular type of method to be used, such as written procedures or written instructions.
质量体系法规所阐明的现行的GMP要求是在食品药品及化妆品法案第520节下所发布的。
The current Good Manufacturing Practices (GMP) requirements set forth in the Quality System (QS) regulation are promulgated under section 520 of the Food, Drug and Cosmetic (FD&C) Act.
下面摘录的是联邦法规21第807.3 (d)中的一些定义，因为它们会影响质量体系法规的应用。
Some definitions from 807.3 (d) are reprinted below because they affect the applications of the QS regulation.
质量体系，生产，法规及其他适当的人员应参加对元器件，装置及工艺设计文档的评审及评估。
Quality system, production, regulatory, and other appropriate personnel should participate in the review, evaluation, and documentation of the components, device, and process design.
如果制造商有符合QS法规的质量体系，MDR报告的频率会是最少的。
If a manufacturer has a quality system as required by the QS regulation, the frequency of MDR reporting should be minimized.
对于如此宽泛的产品范围来说，一个法规规定具体的质量体系要素是不实际的。
It is not practical for a regulation to specify details of quality system elements for such a wide range of products.
因为QS法规涵盖了宽泛品类的产品及生产流程，在具体的质量体系要素中允许某些偏差。
Because the QS regulation covers a broad spectrum of devices and production processes, it allows some leeway in the details of quality system elements.
因为QS法规涵盖了宽泛品类的产品及生产流程，在具体的质量体系要素中允许某些偏差。
Because the QS regulation covers a broad spectrum of devices and production processes, it allows some leeway in the details of quality system elements.
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