2907 - 醫療器材創新與法規實務

Medical Device Innovation and Regulation Affairs

教育目標 Course Target

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。

As the global population ages and social welfare needs increase, the medical device field is moving towards innovation and cost-effectiveness. As an important part of the technology tree and supply chain, Taiwan can not only quickly realize and verify innovations in medical equipment, but also establish a cost-effective mass production base with market scale during the commercialization process.

Regulations play a vital role in the entire life cycle of medical devices. How to convert clinical unmet needs into technical specifications and ensure the safety and effectiveness of the design under regulatory requirements? This requires establishing a complete quality system, conducting risk assessments, and obtaining marketing qualifications through verification procedures. At the same time, supply chain management is also the key to product success to produce high-quality and cost-effective products.

This course will start with an introduction to the research and development of medical device products, allowing students to understand the basic knowledge of medical device development. Next, we will introduce the concept of user needs and translate clinical needs into the actual design and development process. In addition, we will delve into the requirements of current domestic and foreign regulations to help students understand the regulatory requirements that medical device products need to comply with before they are put on the market. This will help students better connect academic research and industrial practice and reduce the gap between industry and academia.

參考書目 Reference Books

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 books:
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’s medical device 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,

評分方式 Grading

評分項目
Grading Method
配分比例
Percentage
說明
Description
出席
Attend
20
作業
Homework
20
期末小組書面報告
Final group written report
30
期末小組上台報告
Final group report on stage
30

授課大綱 Course Plan

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課程資訊 Course Information

基本資料 Basic Information

  • 課程代碼 Course Code: 2907
  • 學分 Credit: 3-0
  • 上課時間 Course Time:
    Wednesday/6,7,8[H207]
  • 授課教師 Teacher:
    郭建榮/湯孝威
  • 修課班級 Class:
    共選1-4(跨域創新學院開)
  • 選課備註 Memo:
    生醫醫材產業微學程之課程
選課狀態 Enrollment Status

目前選課人數 Current Enrollment: 61 人

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