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.
美国人很愿意就医疗器械的标准达成一个协议,然后推敲出不同的合同,用以涵盖-- 比如说-- 电子产品和药品的生产。
The Americans would happily reach one accord on standards for medical devices and them hammer out different pacts covering, say, electronic goods and drug manufacturing.
美国卫生部长迈克尔·利维宣布了一项计划,将允许两国互相对对方的食品、药物和医疗器械生产厂商进行安全检查。
Michael Leavitt, America's health secretary, unveiled a plan to allow both countries to make surprise safety inspections of each other's factories producing food, medical devices and drugs.
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