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This documentation package provides a Risk Management SOP that specifies the process activities and tasks to identify hazards associated with the medical device product, to estimate and evaluate risks, to control the associated risks, and to monitor the effectiveness of the controls throughout all the stages of the product life cycle. Documentation templates include:
Risk Management Standard Operating Procedure
Risk Management Plan
System Hazard Analysis
Design Failure Mode and Effects Analysis (dFMEA)
Process Failure Mode and Effects Analysis (pFMEA)
This documentation package provides a Risk Management SOP that specifies the process activities and tasks to identify hazards associated with the medical device product, to estimate and evaluate risks, to control the associated risks, and to monitor the effectiveness of the controls throughout all the stages of the product life cycle. Documentation templates include:
Risk Management Standard Operating Procedure
Risk Management Plan
System Hazard Analysis
Design Failure Mode and Effects Analysis (dFMEA)
Process Failure Mode and Effects Analysis (pFMEA)