|
週次 |
日期 |
單元主題 |
|
第1週 |
2/23 |
Orientation |
|
第2週 |
3/02 |
1. Overview of medical devices |
|
第3週 |
3/09 |
2. Regulations & standards for medical devices |
|
第4週 |
3/16 |
3. Risk management of medical devices |
|
第5週 |
3/23 |
4. Risk management - risk analysis practices |
|
第6週 |
3/30 |
5. Quality management system for the design & manufacture of medical devices |
|
第7週 |
4/06 |
6. Integrating risk management into quality system |
|
第8週 |
4/13 |
7. Design phase – design control |
|
第9週 |
4/20 |
8. Design phase – usability |
|
第10週 |
4/27 |
9. Design phase – usability (Human factors, Do it by Design) |
|
第11週 |
5/04 |
10. Design phase – software design (develop safety, effective, & reliable medical software) |
|
第12週 |
5/11 |
11. Design phase – software design (practices in software design) |
|
第13週 |
5/18 |
12. Design phase – labeling for medical devices |
|
第14週 |
5/25 |
13. Design/manufacture phases – design transfer & process validation |
|
第15週 |
6/01 |
14. Clinical evaluation & trial |
|
第16週 |
6/08 |
15. Special topic |
|
第17週 |
6/15 |
Final exam. |