医疗器械的上市前批准 PREMARKET APPROVAL OF MEDICAL DEVICES 质量体系规章 QUALITY SYSTEM REGULATION 医疗器械跟踪要求 MEDICAL DEVICE TRACKING REQUIREMENTS ..
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质量体系规章要求输入程序必须明确不完全、有歧义或相冲突的规定。
The QS regulation requires that the input procedures shall address incomplete, ambiguous, or conflicting requirements.
也就是说，检测室是医疗器械制造企业的一部分，而所有与器械相关的部门均应遵守质量体系规章。
That is, the test laboratory is simply a part of a medical device manufacturer of which all device-related divisions shall comply with the QS regulation.
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