The Roles Of Risk Management In A Medical Cycle

A). Risk management is the systematic approach of management policies, procedures and practices to the tasks of analyzing, evaluating, controlling, and monitoring risk. Risk Management is conducted throughout a medical device’s total product life cycle. The primary reason why a risk management should be done is because it is required by FDA, EU, and other countries laws and regulations. Product not complying with risk management requirements cannot be commercialized in certain countries that require it. A very important reason for performing risk management is that is protects the patient, customer, and the overall business from future issues.
B). The role of the cross functional team members is the most prominent in the conception of the …show more content…
They also use post-market data as well as literature to support their probability of adverse events.
• A product surveillance employee submits medical device reports as well as vigilance reports. They also respond to regulatory authority requests for information and generate monthly complaint trend analysis.
• A quality engineer focuses on a risk management plan and shepherd generation of all risk management function deliverables. Second, they ensure consistent application of severities and risk ratings throughout the risk management functions. Third, they prepare a hazard analysis report with FMECA failure modes to reflect hazard that each patient faces for a given device. Fourth, they prepare a risk management report of the medical device benefits as well as the risks. Fifth, they do a post-market update of risk management function based on CAPAs and complaint trends. Lastly, they prepare an essential outputs …show more content…
For example, manufacturers must maintain a system to update risk management files based off of post-market data. Second, PPRs can be done periodic or monthly because they are good triggers to launch RMF investigations for any potential changes in the risk profile of the device. Third, CAPAs are automatic triggers for review of all risk management files for potential risk profile changes. In general, the following questions should be asked when assessing any risk profile changes: Have there been any new failures modes or hazards?, Are the severity ratings for the failure modes accurate?, Has the occurrence rate changed (which would change the residual risk