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I am of the opinion that an FMEA should include parameters for severity, occurence probability and detection probability. However, ISO 14971 only refers to the first two. All examples are with severity and occurence.
Is there any other standard applicable to the medical device industry which refers to the 3 criteria? It would make it much easier to convince management that we should change and use the 3 criteria
Is there any other standard applicable to the medical device industry which refers to the 3 criteria? It would make it much easier to convince management that we should change and use the 3 criteria
