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Archive

All 18 posts, grouped by publication date.

2026

June

  1. SaMD 监管十年 - Chapter 2
    Topic: SaMD
  2. SaMD 监管十年 - Chapter 3
    Topic: SaMD
  3. SaMD 监管十年 - Chapter 1
    Topic: SaMD
  4. Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions 解析 - Chapter 4
    Topic: Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions
  5. Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions 解析 - Chapter 3
    Topic: Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions
  6. Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions 解析 - Chapter 2
    Topic: Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions
  7. Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions 解析 - Chapter 1
    Topic: Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions

May

  1. 中美欧AI医疗器械监管对比 - 实战
    Topic: 中美欧AI医疗器械监管对比
  2. 中美欧AI医疗器械监管对比 - 理论
    Topic: 中美欧AI医疗器械监管对比
  3. AI医疗器械注册审查实操手册（工程团队版）- Chapter 6
    Topic: 人工智能医疗器械注册审查指导原则解读
  4. AI医疗器械注册审查实操手册（工程团队版）- Chapter 5
    Topic: 人工智能医疗器械注册审查指导原则解读
  5. AI医疗器械注册审查实操手册（工程团队版）- Chapter 4
    Topic: 人工智能医疗器械注册审查指导原则解读
  6. AI医疗器械注册审查实操手册（工程团队版）- Chapter 3
    Topic: 人工智能医疗器械注册审查指导原则解读
  7. AI医疗器械注册审查实操手册（工程团队版）- Chapter 2
    Topic: 人工智能医疗器械注册审查指导原则解读
  8. AI医疗器械注册审查实操手册（工程团队版）- Chapter 1
    Topic: 人工智能医疗器械注册审查指导原则解读
  9. AI医疗器械注册审查实操手册（工程团队版）-目录
    Topic: 人工智能医疗器械注册审查指导原则解读
  10. 看到这里的朋友们你们好啊
  11. Hello World
    Topic: Intro