MDR技术文档风险管理计划
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Risk Management Plan
(According to EN ISO 14971:2019)
Product Name:
Model No.:
Document No.:
Version:
Complied by:
Reviewed by:
Authorized by:
Date:
Date:
Date:
Table of Contents
0. Revision History ......................................................................................................................................................................................... 3
1. Scope and Introduction ....................................................................................................................................................................3
1.1 Scope......................................................................................................................................................................................... 3
1.2 Introduction ............................................................................................................................................................................3
2. Definition ............................................................................................................................................................................................... 3
3. Referent Standards and Bibliography ........................................................................................................................................ 3
3.1 Referent Standards ............................................................................................................................................................. 3
3.2 Referent Document ................................................................................................................................................................ 5
4. Risk Management policy and Risk management proces ..................................................................................................6
4.1 Risk Management policy..................................................................................................................................................... 6
4.2 Risk management proces....................................................................................................................................................6
5. Risk Management plan.................................................................................................................................................................... 8
5.1 Scope of the plan ................................................................................................................................................................8
5.2 Product Information ............................................................................................................................................................... 8
5.3 Verification plan....................................................................................................................................................................10
5.4 Members and responsibilities ..................................................................................................................................... 11
5.5 Summary of review activities ......................................................................................................................................... 11
5.6 Risk assessment and risk acceptance criteria .........................................................................................................13
6 Risk Analysis and Contro ............................................................................................................................................................. 15
6.1. Identification of hazards................................................................................................................................................. 15
6.2 The initial hazard analysis , risk assessment , risk control measures and residual risk evaluation for
m 15
6.3 Conclusion of control measures ..................................................................................................................................... 17
6.4 Risk/Benefit analysis and review of overall residual risk acceptability .......................................................... 17
6.5 Adverse event report information .................................................................................................................................17
6.6 Production and post- production information .............................................................................................................17
7. Risks arising from risk control measures ..............................................................................................................................17
8. Completeness of risk contro ......................................................................................................................................................... 17
8.1 Residualriskassessment .....................................................................................................................................................17
8.2 Overall residual risk evaluation ..................................................................................................................................... 17
8.3 Residual risk information disclosure .............................................................................................................................17
9. Evaluation of overallresidualrisk acceptability ...................................................................................................................... 17
10. Production and post -production activities .........................................................................................................................17
11. Conclusion ..................................................................................................................................................................................... 17
0.Revision History
No.
Description
Approved By
State
Effective Date
1.Scope and Introduction
1.1 Scope:
1.2 Introduction:
2.Definition
o Harm:Physical injury and/or damage to health or property.
o Hazard:A potential source of harm
o Risk:The probable rate of occurrence of a hazard causing harm and the degree of severity of the
harm
o Risk Analysis:The investigation of available information to identify hazards and to estimaterisks.
o Safety:Freedom from unacceptable risk of harm
3.Referent Standards and Bibliography
3.1 Referent Standards
No
Document Number
Document Title
摘要：
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RiskManagementPlan(AccordingtoENISO14971:2019)ProductName:ModelNo.:DocumentNo.:Version:Compliedby:Reviewedby:Authorizedby:Date:Date:Date:TableofContents0.RevisionHistory......................................................................................................................................
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作者：冒牌货
分类：专业资料
价格：60质量币
属性：15 页
大小：354.37KB
格式：PDF
时间：2026-01-14
