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醫療器械風險管理報告模板（英文版）（25頁）

• 資料介紹

  醫療器械風險管理報告模板（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

   

• 資料大小：
  1176.3KB
• 所屬類別：
  科研開發
• 更新日期：
  2024-08-21
• 適用行業：
  醫療器械
• 上傳人：
  ricoton_zzq
• 標 簽：

  醫療器械風險管理

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