Robert V. Binder

Posts Tagged ‘safety critical’

Can defective software be safe or secure?

May 24, 2014  |  Process, Software Testing  |  No Comments

Let’s distinguish between systems where the hazards of failure are material (critical) and those that are not. If it bugs don’t matter, they don’t matter. As the question (posed in a LinkedIn forum) asks about safety and security, we’re talking about critical systems.

There is a long standing debate in reliability engineering…

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If It Moves, Test It

The FDA has just published a new draft of guidance about mobile technology in FDA-regulated systems. This guidance is open for comment and isn’t binding yet.
So, what does this mean for testing FDA-regulated products with mobile technology?
The draft guidance defines when mobile platforms are considered as part of a regulated system or not. The criteria for inclusion…

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Competent, Mediocre, or Dangerous?

A Chicago Tribune article recounts how a software bug in an infusion pump lead to brain-death for a patient in 2009 (“Medical Industry Taking Hard Look at Software Faults,” Christine Mai-Duc, Chicago Tribune, August 31, 2011, p. 19)
It reports that the US Food and Drug Administration (FDA), which regulates and…

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