Failure Modes and Effects Analysis (FMEA) is a commonly used technique for risk analysis in the medical device industry. Although it is useful for analyzing the risk of potential device failures, it is not sufficient by itself to analyze and control the risk of harm as required by ISO 14971.
In this month’s webinar, we discuss why FMEA should be treated as only one of the techniques suitable for medical device risk analysis and that it should be complemented with other techniques for a more thorough and complete analysis.
✅Watch the full webinar recording here ➡️naveenagarwalp...
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