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ISO 14971:2007 Requirements (6 Risk Control (6.4 Residual Risk Evaluation,…
ISO 14971:2007 Requirements
3 General Requirements for Risk Management
3.3 Qualification of personnel
3.4 Risk Management Plan
3.2 Management Responsibilities
3.5 Risk Management File
3.1 Risk Management Process
9 Production & Post-production Information
5 Risk Evaluation
6 Risk Control
6.4 Residual Risk Evaluation
6.5 Risk/benefit Analysis
6.3 Implementation of Risk Control Measure(s)
6.6 Risks arising from Risk Control Measures
6.2 Risk Control Option Analysis
6.7 Completeness of Risk Control
6.1 Risk Reduction
4 Risk Analysis
4.2 Intended use and identification of characteristics related to the safety of the medical device
4.3 Identification of hazards
4.1 Risk Analysis Process
4.4 Estimation of the risk(s) for each hazardous situation
8 Risk Management Report
7 Evaluation of Overall Residual Risk Acceptability