Medical Device Hardware Out of Box Failure Rate

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Medical Device Hardware Out of Box Failure Rate

Posted by Michael Webb on Jan 11, 2019 8:10 am

Doing some bench marking and appreciate your thoughts.  What is best in class OOBF rate for medical device hardware first 5 years after release, and after 5 years when manufacturing is more mature?  I know 0 is the target, but what is realistic?  Thanks