What is Risk Management for Medical Devices?
Risk, risk assessment, estimation, evaluation, risk control, and risk management are very well defined in BS EN ISO 14971: 2019. This standard is used for medical devices, IVDR, and has become a harmonized standard for risk management in Canada. Risk management is defined as the “ Systematic application of management policies, procedures, and practices to the tasks of analyzing, evaluating, controlling, and monitoring risks .” What are the steps in the risk management process ? · Identify Hazards, Hazardous Situations in Production and Postproduction, Literature Reviews, Adverse Event Databases · Estimate and Evaluate the Related Risks · Apply Control Measures for Risks · Effectiveness Check · Residual Risks Acceptability Check · ...