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培訓課程表

序號

NO.

培訓課程

Training Course

課時(天)
Period (day)

1

ISO9001:2015質量管理體系要求

ISO9001:2015 Quality Management Systems Requirements

2

2

ISO13485:2016醫療器械質量管理體系適用于法規的要求

ISO13485:2016 Medical Devices--Quality Management SystemsRequirements

2

3

93/42/EEC 2007/47/EC)醫療器械指令

93/42/EEC(2007/47/EC) Medical Device Directive

2

4

98/79/EC體外診斷醫療器械指令

Directives 98/79/EC In VitroDiagnostic Medical Devices

2

5

FDA CFR PART 820 質量體系法規培訓

FDA CFR PART 820 Quality System Regulations Training

3

6

ISO14971 風險管理培訓

ISO14971 Risk Management Training

1

7

潔凈室建立和管理的培訓(ISO14644

Training on Establishment and Management of Clean Room (ISO14644)

2

8

過程確認的培訓

Training on Process Validation

1

9

滅菌確認以及過程監控、包裝確認的培訓

Training on Sterilization Validation, Process Monitoring and Package Validation

3

10

醫療器械技術文檔編制培訓

Training on Preparation of Technical Files for Medical Devices

1

11

質量管理體系內審員培訓

Training for Internal Auditor of Quality Management System

3

12

醫療器械國內法規培訓

Training on Chinese Regulations for Medical Devices

3

13

世界主要經濟體醫療器械法規綜合培訓

Training on Medical Device Regulations of Major Economies in the World

2

14

醫療器械電氣安全和電磁兼容培訓(IEC60601

Training on Electrical Safety and EMC of Medical Devices (IEC60601)

2

15

軟件確認培訓

Training on Software Validation

1

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