Course Description

Course CodeCourse NameCreditsHours
4006011 Medical equipment standards and certification 3.0 4
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