【MDR CE】I類醫療器械TCF技術文檔模板（111頁）

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  【MDR CE】I類醫療器械TCF技術文檔模板（111頁）

  Content
  PART 1 TECHNICAL DOCUMENTATION
  1、Rationale for the qualification as a medical device and the risk class attributed
  2、Description and specification
  3、Technical Specifications of the device
  4、Information to be supplied by the manufacturer
  5、Reference to previous generations of the device and to similar devices
  6、Design and manufacturing information
  7、General safety and performance requirements
  8、Demonstration of conformity
  9、Benefit-risk analysis and Risk management
  10、Pre-clinical and Clinical evaluation data
  11、Records-DOC and certificates
  12、others
  13、EC Authorized Representation Agreement
  PART 2 TECHNICAL DOCUMENTATION ON POST-MARKET SURVEILLANCE
  14、The post-market surveillance system
   

• 資料大小：
  2912.86KB
• 所屬類別：
  科研開發
• 更新日期：
  2022-03-22
• 適用行業：
  醫療器械
• 上傳人：
  unicare
• 標 簽：

  醫療器械TCF技術文檔

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