Software Verification and Validation

In spending two sessions with groups of people who verify and validate medical device software, I got the impression that most effort is spent on testing code (to the requirements that exist). In part, I based this assessment on the amount of questions (e.g., interest by the audience) when code testing was discussed vs. examining requirements. Yet, in reviewing recalls, and my experience in the IVD industry, I suspect that that most errors are caused by wrong requirements (see figure).


 This makes me recall some definitions.

Bug – A coding error that prevents the software from meeting its stated requirement. A divide by zero error is a bug, but if the denominator can never be zero, this bug will never be a failure. Never be zero means the value can never be zero without a code logic statement such as If X <> 0, then … If the code logic statement were present, there would be no divide by zero bug.

Failure – Any deviation from customer expectations. This rather liberal statement is similar to the general definition of quality by ASQ. Each failure must be evaluated by the software / product development team to decide whether they agree and of course deviations have non software causes.

Example – A home glucose meter produces a value over 500 mg/dL. The meter displays ERR1. This is a requirements error. It is known the value is too high ( it could be 501 or 1,000). The meter should say something like HIGH.


One Response to Software Verification and Validation

  1. Interesting article.

    It’s interesting to me that the FDA focus for medical devices is to ensure they’re safe – that they don’t cause bad things to happen.

    Which means that the user interface designs don’t even rate as far as the FDA is concerned. As for connectivity and data standards, they’re not even close to the radar screen.

    You might argue that these issues are failures in requirements. But the challenge is that we (the consumers) don’t actually get to specify any requirements. That’s a shame.

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