| 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 |
|---|---|---|---|---|
| 3204083 | 生醫材料商品化流程 | Commercialization process for biomaterials products | 1.0 | 1 |
| 中文概述 Chinese Description | 本課程目標在教授學生生醫材料與醫療器材技術商品化之實務知識。首先介紹生醫材料產品之特性與市場概況，並由各國醫療法規為出發點，教導學生了解生醫材料產品上市所需之相關程序。特別透過實例之講解，引導學生了解設計、製造、測試三大重點之實務操作。包括產品設計之準則，ISO 13485醫療器材品質系統實務操作，臨床前生物相容測試以及臨床試驗之執行等。課程設計將著重實際法規之講解、實力講解與分析以工廠參觀。將由本校專任教師配合企業講師任教，培育學生迅速進入相關產業工作之能力。 | |||
| 英文概述 English Description | The objective of this course it to illustrate the commercialization process for biomaterials products. The features and the marketing overview of biomaterials will be introduced first. The regulatory issues and the necessary procedures for the commercialization process will be introduced. By the case studies, it is designed to train the students about the necessary concepts of product design, manufacturing and testing processes. It consists of the product design guidelines, ISO 13485 medical products GMP, pre-clinical and clinical tests. | |||
備註：