【MDR CE】I类医疗器械TCF技术文档模板（111页）

• 资料介绍

  【MDR CE】I类医疗器械TCF技术文档模板（111页）

  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
   

• 资料大小：
  2912.86KB
• 所属类别：
  科研开发
• 更新日期：
  2022-03-22
• 适用行业：
  医疗器械
• 上传人：
  unicare
• 标 签：

  医疗器械TCF技术文档

  下载资料 上传资料