The QS regulation is in Part 820 of Title 21 of the Code of Federal Regulations (CFR). This regulation covers quality management and organization, device design, buildings, equipment, purchase and handling of components, production and process controls, packaging and labeling control, device evaluation, distribution, installation, complaint handling, servicing, and records. The preamble describes the public comments received during the development of the QS regulation and describes the FDA Commissioner's resolution of the comments. Thus, the preamble contains valuable insight into the meaning and intent of the QS regulation.
基于1个网页-相关网页
Office of Device Evaluation 评价办公室 ; 械评价办公室 ; 器材管制室
Medical Device Evaluation 仪器检测
Rehabilitation Evaluation Device 康复评定设备
Biological evaluation of medical device 医疗器械生物学评价
evaluation device 评价装置
The pressure controller is a compact device that contains all the measurement and evaluation electronics.
压力控制器是一个紧凑的设备中，包含所有的电子测量和评价。
Quality system, production, regulatory, and other appropriate personnel should participate in the review, evaluation, and documentation of the components, device, and process design.
质量体系，生产，法规及其他适当的人员应参加对元器件，装置及工艺设计文档的评审及评估。
The second-generation device (ARCADIS-3D) provides faster scan and evaluation that reduces time spent.
第二代设备（ARCADIS-3D）可以更快的进行扫描和评估，可以减少所用的时间。
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