Thereportofriskmanagement风险管理评审报告.doc

Thereportofriskmanagement风险管理评审报告.docThe-report-of-risk-management风险管理评审报告
The report of risk management
PRODUCT:
TYPE:
Effective date:
Page:
Document No.:
Version:
Department:
Made
Check
Approval
Contents
1. Foreword 3
2. Scope 3
3. Application information: 3
Policy, directive and standard 3
The information of product 4
Other source of information 4
Terms and definitions 4
Team of risk management: 5
Instruction of product 5
Product survey 5
Class of this product 5
Instruction of function 5
Environment of use 6
4. Risk analysis 7
Risk analysis procedure 7
Intended use/intended purpose and identification of characteristics related to the safety (annex A of ISO 14971:2007) 7
Identification of known or foreseeable hazards and Estimation of the risk(s) for each hazard 17
5. Risk evaluation 23
6. Risk control 23
Risk reduction and implementation of control measure(s) 23
Risks arising from risk control measures 26
Completeness of risk evaluation 26
7. Overall residual risk evaluation: 26
8. Information of in production and post production 27
9. Conclusion 27
Magic stick RISK MANAGEMENT REPORT
1. Foreword
This article is the report of the risk management of this product. This report shows all the potential risks and the reason cause these risks happen, also estimate the rate and the level of all kinds of risks maybe cause the serious result, if a item can not be acceptable, which need to adopt a measure to reduce the risk level and estimate the rate and level after. Finally, make all the items acceptable.
2. Scope
This report is applicable to the product of Allergy Reliever which including the following parts:
1)
3. Application information:
Policy, directive and standard
1) 93/42/EEC（“MDD”）the Directive of medical device.
2) ISO 14971:2000 Medical devices — Applicatio