If a manufacturer has a quality system as required by the QS regulation, the frequency of MDR reporting should be minimized.
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。
The Quality System regulation outlines the minimum elements of a system for designing and producing a medical device.
质量体系法规描述设计和生产医疗器械最少体系要素。
It is not practical for a regulation to specify details of quality system elements for such a wide range of products.
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。
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