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Failure Modes & Effects Analysis (FMEA)

FMEA is based on the assumption that “what can go wrong will go wrong.” FMEA provides a step-by-step approach for identifying all possible failures in a design, manufacturing or assembly processes, or in a product.

Failures are any errors or defects, especially ones that affect the medical professional or patient, and can be potential or actual.

“Effects analysis” refers to studying the consequences of those failures.

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