The-report-of-risk-management风险管理评审报告.pdfVIP

The-report-of-risk-manageme nt 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 Technical File_ Risk Management Report Contents 1. Foreword 3 2. Scope 3 3. Application information: 3 3.1 Policy, directive and standard 3 3.2 The information of product 4 3.3 Other source of information 4 3.4 Terms and definitions 4 3.5 Team of risk management: 5 3.6 Instruction of product 5 3.7 Product survey 5 3.8 Class of this product 5 3.9 Instruction of function 5 3.10 Environment of use 6 4. Risk analysis 7 4.1 Risk analysis procedure 7 4.2 Intended use/intended purpose and identification of characteristics related to the safety (annex A of ISO 14971:2007) 7 4.3 Identification of known or foreseeable hazards and Estimation of the risk(s) for each hazard 17 5. Risk evaluation