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Glossary Term
Failure Modes and Effects Analysis (FMEA)
Definition
Failure Modes and Effects Analysis (FMEA) is a systematic risk assessment tool used to identify potential failure modes in a product, process, or system, evaluate their effects, and prioritize actions to mitigate risks. It is commonly applied in the MedTech industry to enhance the safety and reliability of medical devices throughout their lifecycle.
Relevance to the MedTech Industry
FMEA helps medical device manufacturers proactively identify and address potential risks, ensuring compliance with regulatory requirements such as ISO 14971 (Risk Management for Medical Devices). By systematically analyzing failure modes and their potential impacts, FMEA enhances product safety, quality, and performance, reducing the likelihood of recalls or adverse events.
Additional Information & Related Terms
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