Training Course
NO. | Training Course | Period (day) |
1 | ISO9001:2015 Quality Management Systems Requirements | 2 |
2 | ISO13485:2016 Medical Devices--Quality Management SystemsRequirements | 2 |
3 | FDA CFR PART 820 Quality System Regulations Training | 3 |
4 | Training for Internal Auditor of Quality Management System | 3 |
5 | Training on Establishment and Management of Clean Room (ISO14644) | 2 |
6 | Training on Process Validation | 1 |
7 | Training on Sterilization Validation, Process Monitoring and Package Validation | 3 |
8 | Training on Chinese Regulations for Medical Devices | 3 |
9 | EU 2017/745 Medical Device Regulation | 2 |
10 | EU 2017/746 on in vitro diagnostic medical devices | 2 |
11 | Training on Medical Device Regulations of Major Economies in the World | 2 |
12 | ISO14971 Risk Management Training | 1 |
13 | Training on Software Validation | 1 |
14 | Training on Preparation of Technical Files for Medical Devices | 1 |
15 | Training on Electrical Safety and EMC of Medical Devices (IEC60601) | 2 |
