Each manufacturer shall establish and maintain a quality system that is appropriate for the specific medical device (s) designed or manufactured, and that meets the requirements of this part.

每个工厂应建立并保持一个质量体系是适宜的特定医疗器械的设计或制造的，并且符合要求的这一部分。

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That's in contrast to mainframe applications, or even versions of the "open" Unix operating system that were specific to a given computer manufacturer's hardware.

FORBES