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FMEA Analysis

NeoMedix uses Failure Mode & Effects Analysis (FMEA) as a risk assessment tool to systematically identify product or process characteristics that constitute potential risks to patient safety, product acceptance or product profitability. Our FMEA procedure is designed to identify all potential failure modes, the effects, the causes, and the current controls. For potential causes, we make an estimate of the probability of occurrence, assessment of severity, and an estimate of detection. Finally, NeoMedix creates a risk priority ranking along with a list of recommended actions.

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