Enterprise internal training service
Cosmos Biomed has many years of experience in the medical device industry training service , and our rich regulatory experience can help medical device practitioners quickly grasp the update status of international regulations. We can help your new employee understand the life cycle of medical device products and the system structure of analytical quality. To help companies improve their international competitiveness, we welcome inquiries for internal training.
Training Scope
1. ISO 13456:2016 quality system management regulation introduction
2. Design control progress introduction
3. ISO 14971 Risk management of medical device training
4. Post market Surveillance introduction
5. Process validation practice training
6. Software validation practice training
7. Sterilization validation (Gamma/EO/Moisture heat sterilization) practice training
8. Product package validation practice training
9. ISO 10993 Biocompatibility evaluation under risk management process training
10. UDI Unique Device Identification System training
11. USFDA 510k submission practice training
12. European CE mark introduction and registration practice
13. QSR training and auditing key point practice
14. Taiwan FDA registration practice training
15. CE technical documentation and preparation practice training
16. Clinical evaluation documentation practice training