The specifications are device master record (DMR) spec document or the specifications appear in a DMR drawing or procedure.
这些规格书属于设计主记录（DMR）规格文件或者是在DMR图档或流程中出现的规格文件。
Pilot devices may be distributed after design validation of initial units is completed if they meet all of the device master record and other GMP requirements.
如果初期产品符合器械主记录和其他GMP的要求，并且通过设计验证，那么试生产的产品可以进入流通。
A set of design input requirements, when converted to engineering terminology, finalized and accepted as part of the device master record is called a device or product specification.
当设计成套的输入的规定被转换成工程术语，并在器械主记录中得到最终确认并成为记录一部分，这些成套规定就被称之为器械或产品规格。
Complying with the QS regulation assures that the manufacturing processes can consistently achieve desired levels of quality and that the finished device meets its device master record specifications.
顺应QS法规确保制造流程可以持续达到期望的质量水平，并使医疗器械达到其设计主文件规格要求。
Complying with the QS regulation assures that the manufacturing processes can consistently achieve desired levels of quality and that the finished device meets its device master record specifications.
顺应QS法规确保制造流程可以持续达到期望的质量水平，并使医疗器械达到其设计主文件规格要求。
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