基本素養 Basic Literacy
■ 理解專業醫學與工程倫理及社會責任
Understand professional medical and engineering ethics and society responsibility
□ 培養有效溝通、表達及團隊合作精神之能力
Cultivate effective communication, presentation, and cooperation
□ 培養終身學習的能力
Lifelong learning ability
□ 培養具備國際觀及外語能力
Global vision and foreign languages
核心能力 Competence
■ 特定領域之專業知識
Specific fields of expertise
■ 創新思考及獨立解決問題之能力
Innovative thinking and independent problem solving ability
□ 撰寫專業論文之能力
The professional thesis writing ability
■ 良好的國際觀
Perfect international perspective
□ 與不同領域人員協調整合之能力
Coordination and integration ability with different areas personnel
■ 策劃及執行專題研究之能力
Planning and execution of a research project capability
■ 領導、管理及規劃之能力
Leadership, management and planning ability
□ 終身自我學習成長之能
Growth of life-long self-learning ability
課程概述 Course Description
一、教學內容:本課程講授醫療器材相關之專利與醫療器材法規之基本認識，並配合實務案例演練進行專利與法規的分析比較。透過強化學員對於專利與法規面之了解，結合學員對於創新醫療器材商品化的基本訓練，逐步構思聚焦於醫療器材的法規策略，強化醫療器材商品化的能力。 二、教學目標: 1. 培養醫療器材專利法知識與分析能力。 2. 培養醫療器材法規面知識與檢索能力。 3. 培養從事醫療器材新創及創新的基本能力。 4. 培養修課學員制定醫療器材法規策略及管理能力。1.Course Description: Taking this course can help you learn how to implement patent law and regulation on innovative medical devices accompanying major serious case studies. Moreover, we offer concrete content to strengthen students’ analytical ability and be more familiar with the commercialization of the innovative medical device. The practical practice is the core value of this course. 2.Course Objectives: 1. Cultivate the knowledge and analysis ability of medical device patent law. 2. Cultivate the knowledge of medical device regulations and search capabilities. 3. Cultivate the basic ability to engage in the innovation of medical devices. 4. Cultivate trainees to engaging in innovating medical devices and starting up a related business."
課程學習目標 Course Objectives
課程進度 Progress Description
| 進度說明 Progress Description | |
|---|---|
| 1 | Basic understating of medical device regulation |
| 2 | Risk Analysis / Management (ISO14971) |
| 3 | Clinical Evaluation & Post-Market Surveillance of Medical Device |
| 4 | Design and Development Control Procedure |
| 5 | IEC 60601-1 assessment, software validity (IEC 62304) and usability assessments (IEC 62366) |
| 6 | Regulatory concerns while adopting System on Chip as a key component of Medical Device |
| 7 | SaMD/MDSW |
| 8 | The medical device regulation of major markets. The US, EU, China and Japan |
| 9 | Planning the regulatory pathway of medical device |
| 10 | Indroduction to Intellectual Property (IP) Law |
| 11 | Speech : Introduction to U.S Patent Law |
| 12 | Protecting technical innovation |
| 13 | Speech : Biotechnological inventions : Law, Pratice and Challenge |
| 14 | IP, R&D and knowledge transfer /The commercialisation of IP |
| 15 | Speech : Legal decision-making in patent portfolios of pharmaceutical and medical device research |
| 16 | International IP Law |
| 17 | _Patent Strategies for the Pharmaceutical, Biotech, and Medical Device Industries in international environment |
| 18 | Students Projects |
以上每週進度教師可依上課情況做適度調整。The schedule may be subject to change.
課程是否與永續發展目標相關調查
Survey of the conntent relevant to SDGs
本課程與SDGs相關項目如下：
This course is relevant to these items of SDGs as following:
- 健康與福祉 (Good health and Well Being)
- 工業、創新與基礎建設 (Industry Innovation and infrastructure)
有關課程其他調查 Other Surveys of Courses
1.本課程是否規劃業界教師參與教學或演講? 否Is there any industry specialist invited in this course? How many times? No
2.本課程是否規劃含校外實習(並非參訪)? 否
Are there any internships involved in the course? How many hours? No
3.本課程是否可歸認為學術倫理課程? 是，含學術倫理課程 2 小時
Is this course recognized as an academic ethics course? In the course how many hours are regarding academic ethics topics? Yes, about 2 hours
4.本課程是否屬進入社區實踐課程? 否
Is this course recognized as a Community engagement and Service learning course? Which community will be engaged? No