ارزیابی ریسک به روش تجزیه و تحلیل عوامل شکست

The basis of FMEA is identifying failure modes. ... FMEA is a very good tool and can be extremely helpful for design and development teams while evaluating materials, components, and sub-assemblies comprising medical devices. But FMEA is more of a reliability tool rather than a risk management system.۲۰

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