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