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Risk Management
Risk management involves the identification, understanding control, and prevention of failures that can result in hazards when people use medical devices. Hazard analysis, risk analysis and xFMEAs play a key role in the development of medical devices design.
At Pivotal, we are seasoned practitioners of risk mitigation, developing and implementing processes prior to the advent of ISO 14971. Our methods and process involve the identification and control of harm to prevent failures that can result in hazards to those using medical devices. Hazard Analysis, Risk Analysis and xFMEAs are important considerations in medical device design and our methodology starts at requirement documentation and goes through verification and validation, including user studies.
We start with the Risk Management Plan followed by a top-level Hazard Analysis where we postulate intended use and business risks. We follow this by a deeper level Risk Analysis which results in Risk Mitigations/Controls which become requirements for the product. If the residual risk is unacceptable, further analysis is performed. If an assessment of risk resulting in harm is high, we then perform xFMEAs. We practice Risk Management throughout the development cycle.
This process results in a well-designed product with reduced risks and a clear path to safe use. It also serves as a key point of analysis that is required in any medical device submission.
