Regulatory and Ethics
本课程讲授医疗器械法规体系与生物医学研究伦理规范，涵盖美国FDA 510(k)与PMA路径、欧盟CE MDR、中国NMPA注册流程、ISO 13485质量管理体系、IEC 60601安全标准。学生学习临床试验设计、风险管理与上市后监督，并讨论人体试验知情同意、患者隐私、AI医疗算法公平性等伦理议题，培养职业责任感与合规意识。
This course covers medical device regulatory systems and biomedical research ethics, including FDA 510(k) and PMA pathways, EU CE MDR, China NMPA registration, ISO 13485 quality management, and IEC 60601 safety standards. Students study clinical trial design, risk management, and post-market surveillance, and discuss informed consent, patient privacy, and AI fairness in healthcare, building professional responsibility and compliance awareness.
学生以一款新型连续血糖监测仪为对象，撰写FDA 510(k)申报材料，包含器械描述、实质等价性对比、性能测试方案、风险管理报告与临床证据综述，并就申报中的伦理合规要点进行课堂答辩。
For a novel continuous glucose monitor, students draft an FDA 510(k) submission including device description, substantial equivalence comparison, performance testing plan, risk management report, and clinical evidence summary, followed by a class defense on ethical and compliance considerations.