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Beihang University

生物医学产品标准及生产法规

Beihang University via XuetangX

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Overview

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针对国内、外生物医学产品标准与生产法规，结合案例教学，向学生讲解生物医学相关产品以及其发展趋势，介绍生物医学产品设计、检测与制造、申报注册、生产、临床应用全流程涉及到的产品标准和生产法规。


Syllabus

  • 第一章 绪论
    • 第二章 医疗器械监管体系
      • 第三章 医疗器械质量管理
        • 第四章 药品质量管理
          • 第五章 医疗器械生物评价与创新产品特别审批程序
            • 第六章 医疗器械注册与临床应用管理
              • 第七章 案例
                • 期末考试

                  Taught by

                  Lizhen Wang, Yan yao, Wentao Feng, Xili Ding, Shan Tian, Yuanming Gao, and Qiao Li

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