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  • 公开课培训日程表

     

     

    培训

    时间

    培训课程

    Training Course

    课时(天)
    Period (day)

        2023.01

    IVD欧洲法规(IVD
    IVD European Regulation
    2
    2023.02
    医疗器械法规(MDR
    Regulation (EU) 2017/745 on medical devices
    2

    2023.03

    欧盟授权代表
    EU Representative

    2

    2023.04

    瑞士医疗器械法规(MedDO)
    Swiss regulations on medical Devices(MedDO

    2

    2023.05

    英国医疗器械法规(MHRA)
    British Medical Device Code(MHRA)

    2

    2023.06

    自由销售证书
    Free Sales Certificate

    2

    2023.07

    FDA CFR PART 820 质量体系法规培训

    FDA CFR PART 820 Quality System Regulations Training

    2

    2023.08

    ISO13485:2016医疗器械质量管理体系适用于法规的要求
    ISO13485:2016 Medical Devices--Quality Management Systems Requirements

    2

    2023.09

    医疗器械法规(MDR
    Regulation (EU) 2017/745 on medical devices

    2

    2023.10

    FDA510K
    510(k) Premarket Notification

    2

    2023.11

    MDSAP医疗器械单一审核程序
    Medical Device Single Audit Program (MDSAP) 

    2

    2023.12

    FDA CFR PART 820 质量体系法规培训

    FDA CFR PART 820 Quality System Regulations Training

    2

     


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