• 首页
  • > 服务
  • > 培训业务
  • > 培训课程表

  • 培训课程表


     

    序号

    NO.

    培训课程

    Training Course

    课时(天)
    Period (day)

    1

    ISO9001:2015质量管理体系要求

    ISO9001:2015 Quality Management Systems Requirements

    2

    2

    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

    3

    FDA CFR PART 820 美国医疗器械质量体系法规培训
    FDA CFR PART 820 Quality System Regulations Training

    3

    4

    质量管理体系内审员培训
    Training for Internal Auditor of Quality Management System

    3

    5

    洁净室建立和管理的培训(ISO14644
    Training on Establishment and Management of Clean Room (ISO14644)

    2

    6

    过程确认的培训
    Training on Process Validation

    1

    7

    灭菌确认以及过程监控、包装确认的培训
    Training on Sterilization Validation, Process Monitoring and Package Validation

    3

    8

    中国医疗器械法规培训
    Training on Chinese Regulations for Medical Devices

    3

    9

    EU 2017/745 欧盟医疗器械法规
    EU 2017/745 Medical Device Regulation

    2

    10

    EU 2017/746 欧盟体外诊断医疗器械法规
    EU 2017/746 on in vitro diagnostic medical devices

    2

    11

    世界主要经济体医疗器械法规综合培训
    Training on Medical Device Regulations of Major Economies in the World

    2

    12

    ISO14971 风险管理培训
    ISO14971 Risk Management Training

    1

    13

    软件确认培训
    Training on Software Validation

    1

    14

    医疗器械技术文档编制培训
    Training on Preparation of Technical Files for Medical Devices

    1

    15

    医疗器械电气安全和电磁兼容培训(IEC60601
    Training on Electrical Safety and EMC of Medical Devices (IEC60601)

    2