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公开课培训日程表

培训

时间

培训课程

Training Course

课时(天)
Period (day)

2020.03

医疗器械法规(MDR)
Regulation (EU) 2017/745 on medical devices

2

2020.04

FDA(510K)
510(k) Premarket Notification

2

2020.05

MDSAP医疗器械单一审核程序
Medical Device Single Audit Program (MDSAP) 

2

2020.06

医疗器械法规(MDR)
Regulation (EU) 2017/745 on medical devices

2

2020.07

FDA CFR PART 820 质量体系法规培训

FDA CFR PART 820 Quality System Regulations Training

2

2020.08

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

2020.09

医疗器械法规(MDR)
Regulation (EU) 2017/745 on medical devices

2

2020.10

FDA(510K)
510(k) Premarket Notification

2

2020.11

MDSAP医疗器械单一审核程序
Medical Device Single Audit Program (MDSAP) 

2

2020.12

FDA CFR PART 820 质量体系法规培训

FDA CFR PART 820 Quality System Regulations Training

2

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