FDA要求医疗器械制造商是在受控状态下运行。
FDA requires manufacturers of medical devices to operate in a state-of-control.
这些实验室可以向许多客户提供服务，他们中的很多并非医疗器械制造商。
These laboratories may provide services to a number of customers, many of which are not medical device manufacturers.
医疗器械制造商然后根据其满足所制定规格的能力评价其供应商，合同承包商及顾问。
The manufacturers shall then assess their suppliers, contractors, and consultants based on their ability to meet the established specifications.
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