-Risk Management Integration for the Organization based Regulatory Drivers for Medical Devices
-Develop Safety & Risk Management Plan for the Organization based on the Product.
-Risk Estimation – Inputs - Identify Hazard Scenarios
-Develop Risk Assessment Methods and Estimate the Risk of Harm Associated with the Scenario
-Design Verification/Validation –Develop Risk Control, Monitoring & Effectiveness
-Evaluation of Overall Residual Risk Acceptability
-Generate Risk Management Report
-Production and Post-production Information Updates