如果一个制造商或一国监管机构通过我们的资格预审,其医疗产品就可放心采购。
If we prequalify a manufacturer or a national regulatory authority, their medical products can be procured with confidence.
医疗器械制造商应建立并维护流程以确保其所采购或者接收的产品或服务满足其规格要求。
Manufacturers shall establish and maintain procedures to ensure their purchased and otherwise received products and services conform to their specified requirements.
成品制造商当其购买产品或服务时应满足QS法规特别是820.50关于采购的要求。
The finished device manufacturer shall meet the requirement of the QS regulation, particularly 820.50, Purchasing, when they obtain products or services.
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