隨著全球人口老化和社會福利需求的增加，醫療器材領域正朝著創新和性價比的方向發展。台灣作為科技樹和供應鏈的重要一環，不僅能夠快速實現和驗證醫療器材的創新，還能在商品化過程中建立具有市場規模的性價比量產基地。
在醫療器材的全生命週期中，法規起著至關重要的作用。如何在法規要求下，將臨床未滿足的需求轉化為技術規格，並確保設計的安全有效？這需要建立完善的品質系統、進行風險評估，並通過驗證程序取得上市資格。同時，供應鏈管理也是產品成功的關鍵，以產出高品質且成本合理的產品。
本課程將從醫療器材產品的研發介紹開始，讓學員瞭解醫療器材開發的基本知識。接著，我們將引入使用者需求的概念，將臨床需求轉化為實際設計和開發過程。此外，我們將深入探討國內外現行法規的要求，以幫助學生理解醫療器材產品上市前所需遵守的法規要求。這將有助於學生更好地銜接學術研究和產業實務，減少產學之間的落差。
With the global aging population and increasing demand for social welfare, the medical equipment sector is developing towards innovation and sex-price ratio. As an important link in science and technology trees and supply chains, Taiwan can not only quickly realize and verify the innovation of medical equipment, but also establish a market-scale price-to-performance production base in the process of commercialization.
Laws play an important role in the entire life cycle of medical equipment. How to convert unsatisfied clinical needs into technical specifications under the requirements of the law and ensure the safety and effectiveness of the design? This requires establishing a complete quality system, conducting risk assessment, and obtaining listing qualifications through verification procedures. At the same time, supply chain management is also the key to product success, to produce high-quality and affordable products.
This course will begin with the introduction of the research and development of medical equipment products, allowing students to understand the basic knowledge of medical equipment development. Next, we will introduce the concept of user needs and transform clinical needs into actual design and development processes. In addition, we will explore the requirements of existing laws and regulations at home and abroad in depth to help students understand the laws and regulations that must be followed before they are launched. This will help students better integrate academic research and industrial practices, reducing the gap between production.
參考書:
Biodesign: The Process of Innovating Medical Technologies
https://www.amazon.com/Biodesign-Process-Innovating-Medical-Technologies/dp/0521517427
臺灣醫療器材 CDMO 的未來、產業趨勢及重要性
https://forum.nhri.edu.tw/book-112-6/
ISO standards：QMS、ISO13485、ISO14971、ISO10993-1、ISO11135、ISO11137、ISO17665、ISO62304、IEC/EN 60601-1、ISO11607、
Reference:
Biodesign: The Process of Innovating Medical Technologies
https://www.amazon.com/Biodesign-Process-Innovating-Medical-Technologies/dp/0521517427
The future, industry trends and importance of Taiwan medical equipment CDMO
https://forum.nhri.edu.tw/book-112-6/
ISO standards: QMS, ISO13485, ISO14971, ISO10993-1, ISO11135, ISO11137, ISO17665, ISO62304, IEC/EN 60601-1, ISO11607,
| 評分項目 Grading Method | 配分比例 Grading percentage | 說明 Description |
|---|---|---|
| 出席出席 Attend |
20 | |
| 作業作業 Action |
20 | |
| 期末小組書面報告期末小組書面報告 Final group letter report |
30 | |
| 期末小組上台報告期末小組上台報告 The final group came to the stage to report |
30 |
