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ROI CalculatorFMEA is a structured risk analysis method used to identify how a process or product can fail, assess the impact, and prioritize controls before failures occur.
FDA design and process controls expect risk analysis as part of product and process development. ICH Q9 formally defines risk management principles for pharmaceutical quality systems, including tools such as FMEA. ISO 13485 and ISO 14971 require risk management throughout the device lifecycle.
Why it matters: FMEA prevents defects early and strengthens regulatory defensibility.
