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(接5月下)2研究方法与实施方案北京市医疗器械技术审评中心对于X射线管组件类产品的技术审评已经积累了丰富的实践经验,通过认真研读相关的法律法规、国家标准、行业标准,并通过对历史注册资料的搜集筛查,调研北京市相关企业,以及与技术专家临床专家的研讨,汇总了X射线管组件类产品的技术审评关注点,编写了技术审评规范初稿,最后经过广泛征求意见形成了终稿。3 X射线管组件类产品技术审评关注点
(Next May) 2 research methods and implementation of the Beijing Medical Device Technical Evaluation Center for X-ray tube components of the technical review of the product has accumulated rich practical experience, through careful study of relevant laws and regulations, national standards, Industry standards and research through the history of the collection and screening of information to investigate the relevant enterprises in Beijing, and clinical experts and technical experts to discuss the summary of X-ray tube components of the technical review of the concerns of the preparation of the technical review norms The first draft, finally formed a final draft after extensive consultation. 3 X-ray tube assembly product technical review concerns