风险管理报告英文范例Risk Management
Risk Management ReportProduct Name: 【产品名称】
Model: 【产品型号】
Document No.: 【文件编号】
Edition: 【版本】
Index
Chapter 1: Description....... 4
1.1 Product introduction.4
1.2 Purpose and scope....4
1.3 Product expected life time.4
1.4 Contraindication.......4
1.5 Side effects/complications: ........4
1.6 Precautions and warning:..4
1.7 Description of risk management implementation .5
1.8 Applied standard list.6
1.9 Risk Assessment team and responsibility.....6
Chapter 2 Risk Analysis..... 8
2.1Risk Accept Level.....8
2.2 Intended use and reasonably foreseeable misuse ..9
2.3 Identification of the safety related characteristic .........10
Chapter 3 Risk Evaluation and control....... 34
3.1 Risk Evaluation and Risk Control.....34
3.2 Residual risk evaluation..34
3.3 Benefit-risk Analysis.......35
3.4 Risks arising from risk control measures...35
3.5 Completeness of Risk Control .35
Chapter 4 Evaluation of overall residual risk..... 36
Chapter 5 Risk Management Review. 37
5.1 Risk Management review input ........37
5.2 Implementation of risk management plan..37
5.3 Overall residual risk acceptable evaluation.........37
5.4 Reviewed document........38
Chapter 6 Production and post-production information ........ 40
Chapter 7 Risk Management Review Conclusion. 44
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