| 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 |
|---|---|---|---|---|
| 4006011 | 醫療器材規範與認證 | Medical equipment standards and certification | 3.0 | 4 |
| 中文概述 Chinese Description | 醫療器材簡介、我國醫療器材管理制度與發展趨勢、FDA/ISO醫療器材認證制度、醫療器材開發流程與風險分析、醫療器材生物相容性質測試 (ISO 10993)、醫療器材醫電相容性質測試、醫療器材軟體驗證、良產品製造規範(Good Manufacturing Practice, GMP)、優良實驗室操作(Good Laboratory Practice, GLP)、優良細胞操作規範 (Good Tissue Practice, GTP)、醫療器材優良臨床試驗(Good Clinical Practice, GCP)、醫療器材臨床試驗基本考量：醫學倫理與病患安全、醫療器材的臨床試驗與查核、醫療器材上市審查、案例討論（I）人工植體、案例討論(II) 軟體開發、案例討論(III) 血液透析相關產品、Final Exam / 期末報告 | |||
| 英文概述 English Description | Medical Equipment Introduction 2. Taiwan medical equipment management system and development trends 3. FDA / ISO certification system of medical equipment 4. Medical equipment development process and risk analysis 5. Biocompatibility of medical devices quality test (ISO 10993) 6. Medical equipment compatible with medical electrical test 7. Medical equipment software verification 8. Good Manufacturing Practice, GMP 9. Good Laboratory Practice, GLP 10. Good Tissue Practice, GTP 11. Good Clinical Practice, GCP 12. The basic considerations of clinical trials of medical equipment: Medical Ethics and Patient Safety 13. Medical devices in clinical trials and Audit 14. Medical equipment market review 15. Case study (I) implant 16. Case study (II) Software Development 17. Case study (III) hemodialysis related products 18. Final Exam / Final report | |||
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