医疗器械风险管理报告模板（英文版）（25页）

• 资料介绍

  医疗器械风险管理报告模板（英文版）

  Contents

  1 Foreword 3

  2 Scope 3

  3 Application information 3

  3.1 Policy, directive and standard 3

  3.2 The information of product 3

  3.3 Other source of information 3

  3.4Terms and definitions 3

  3.5 Team of risk management 4

  3.6 Instruction of product 4

  3.7 Product survey

  3.8Class of this product 5

  4 Risk analysis 5

  4.1 Risk analysis procedure 6

  4.2 Intended use/intended purpose and identification of characteristics related to the 6

  safety

  4.3 Identification of known or foreseeable hazards and Estimation of the risk(s) for 8

  each hazard

  4.4 Risk Estimation 12

  5 Risk evaluation 13

  5.1 Risk reduction and implementation of control measure(s) 13

  5.2 Risks arising from risk control measures 14

  5.3 Completeness of risk evaluation 14

  6 Risk control 15

  6.1 Risk reduction and implementation of control measure(s) 15

  6.2 Risks arising from risk control measures 16

  6.3 Completeness of risk evaluation 16

  7Overall residual risk evaluation 16

  8Information of in production and use 16

   

  9 Conclusion 17

   

• 资料大小：
  1176.3KB
• 所属类别：
  科研开发
• 更新日期：
  2024-08-21
• 适用行业：
  医疗器械
• 上传人：
  ricoton_zzq
• 标 签：

  医疗器械风险管理

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