| 課程編碼 Course Code | 中文課程名稱 Course Name (Chinese) | 英文課程名稱 Course Name (English) | 總學分數 Credits | 總時數 Hours |
|---|---|---|---|---|
| 5606002 | 醫療器材研發與認證 | Design and Certification of Medical Devices | 3.0 | 3 |
| 中文概述 Chinese Description | 先修課程：負責教授同意。 在台灣，醫療器材產業是生物科技裡最耀眼的一項，相對於其他產品而言，它具有需較高的安全性要求與需經過醫療法規認證。本課程分成六大上課主題：(1)醫療器材之定義、(2)醫療器材之市場介紹、(3)醫療器材之研發模式、(4)醫療器材之測試評估、(5)醫療器材之法規認證與(6)實務案例研討。 | |||
| 英文概述 English Description | In Taiwan, medical devices industry is the most glaring term in all areas of biotechnology. In comparison with the other products, the medical devices should provide the higher requirement for safety and approve the qualification of medical laws. Six topics are introduced and discussed in this class: (1) definition of medical device, (2) introduction to market of medical devices, (3) research and design of medical devices, (4) safety evaluation of medical devices, (5) license certification of medical devices, and (6) several case studies. | |||
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