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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

FDA CFR PART 820 美國醫療器械質量體系法規培訓
FDA CFR PART 820 Quality System Regulations Training

3

4

質量管理體系內審員培訓
Training for Internal Auditor of Quality Management System

3

5

潔凈室建立和管理的培訓(ISO14644)
Training on Establishment and Management of Clean Room (ISO14644)

2

6

過程確認的培訓
Training on Process Validation

1

7

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

8

中國醫療器械法規培訓
Training on Chinese Regulations for Medical Devices

3

9

EU 2017/745 歐盟醫療器械法規
EU 2017/745 Medical Device Regulation

2

10

EU 2017/746 歐盟體外診斷醫療器械法規
EU 2017/746 on in vitro diagnostic medical devices

2

11

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

12

ISO14971 風險管理培訓
ISO14971 Risk Management Training

1

13

軟件確認培訓
Training on Software Validation

1

14

醫療器械技術文檔編制培訓
Training on Preparation of Technical Files for Medical Devices

1

15

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

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