|
週次 |
日期 |
單元主題 |
|
第1週 |
2/18 |
Orientation &
Business strategy for medical devices |
|
第2週 |
2/25 |
Overview of medical devices |
|
第3週 |
3/04 |
Regulation |
|
第4週 |
3/11 |
Risk management of medical device |
|
第5週 |
3/18 |
Risk management of medical device |
|
第6週 |
3/25 |
Risk analysis |
|
第7週 |
4/01 |
Design phase – design control |
|
第8週 |
4/08 |
Design phase – human factors |
|
第10週 |
4/22 |
Design phase – human factors |
|
第11週 |
4/29 |
Design phase – Practices in software design |
|
第12週 |
5/06 |
Develop safety, effective, |
|
第13週 |
5/13 |
Labeling for medical devices |
|
第14週 |
5/20 |
Quality system for the design & manufacture of medical devices |
|
第15週 |
5/27 |
Quality system for the design & manufacture of medical devices |
|
第16週 |
6/03 |
Integrating Risk Management into Quality System |
|
第17週 |
6/10 |
Clinical trial |