|
週次 |
日期 |
單元主題 |
|
第1週 |
|
Orientation |
|
第2週 |
|
00 - Overview of medical devices |
|
第3週 |
|
01 - Design and project management (system engineering) |
|
第4週 |
|
02 - Regulations & standards for medical devices |
|
第5週 |
|
03 - Quality system for design & manufacture of medical devices |
|
第6週 |
|
04 - Risk management of medical devices |
|
第7週 |
|
05 - Risk management - risk analysis |
|
第8週 |
|
06 - Design phase – design control |
|
第9週 |
|
06-1 - Design phase – Good Design Practice |
|
第10週 |
|
07 - Design phase – Usability (human factors) |
|
第11週 |
|
08 - Design phase – human factors – Do it by design! |
|
第12週 |
|
09 -Design phase – software |
|
第13週 |
|
10 - Design phase – software – develop safe, effective & reliable medical software |
|
第14週 |
|
11 - Labeling of medical devices |
|
第15週 |
|
12 – Clinical trial |
|
第16週 |
|
07 - Implement risk management to the quality system of medical devices |