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陕西省医疗器械质量监督检验院 >> 信息动态 >> 最新动态 >> 正文
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陕西省医疗器械质量监督检验院 >>最新动态 >> 正文
我院顺利通过地方标准结题评审
作者:未知 信息来源:本站原创 点击数:320 更新时间:2019/12/6 7:14:19
          2019年12月5日,省市场监督管理局组织召开了由省器械检验院牵头制订的《3D打印医疗器械生产质量管理规范》地方标准评审会。来自陕西省新药审评中心、陕西省市场监督管理局、西安交通大学、空军军医大学、西安马克医疗科技技术有限公司、维度西安生物医疗科技有限公司等单位的专家参与了标准送审稿的评审。
  评审会上,标准起草组代表向评审专家组汇报了标准制订背景、意见征集情况汇总和标准送审稿的详细内容。专家组听取汇报并对标准条款逐条进行了审查,就该地方标准与目前国内现行法规及国家、行业标准之间的符合性、制定标准的必要性、技术上的成熟性和可操作性等方面问题进行了现场质询和分析论证。最后经专家组合议,对标准的送审稿提出了宝贵的意见和修改建议。
经过一天紧张有序的评审,专家组一致认为,省器械检验院牵头制订的该地方标准内容详实,满足增材制造医疗器械生产质量管理的要求,项目条款客观准确。通过此次地方标准评审论证,进一步提升了我院标准化制修订的工作能力,同时对我省增材制造医疗器械产业发展和科学监管有着重要的指导和参考意义。

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