The Quality Systemregulation 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。
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This manual will assist you in developing a quality system that meets the intent of the FDA Quality Systemregulation.
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。
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The research can offer the gist for the system operators to learn the operating state of the units accurately and select the units correctly that can meet the systemregulation demand.