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 SystemsRequirements

2

3

93/42/EEC （2007/47/EC）医疗器械指令

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

2

4

98/79/EC体外诊断医疗器械指令

Directives 98/79/EC In VitroDiagnostic Medical Devices

2

5

FDA CFR PART 820 质量体系法规培训

FDA CFR PART 820 Quality System Regulations Training

3

6

ISO14971 风险管理培训

ISO14971 Risk Management Training

1

7

洁净室建立和管理的培训（ISO14644）

Training on Establishment and Management of Clean Room (ISO14644)

2

8

过程确认的培训

Training on Process Validation

1

9

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

10

医疗器械技术文档编制培训

Training on Preparation of Technical Files for Medical Devices

1

11

质量管理体系内审员培训

Training for Internal Auditor of Quality Management System

3

12

医疗器械国内法规培训

Training on Chinese Regulations for Medical Devices

3

13

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

14

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

15

软件确认培训

Training on Software Validation

1