Robert V. Binder

Posts Tagged ‘medical devices’

Panel Discussion on Open Source Testing Tools

A few days ago, I participated in a panel discussion on open source tools for testing at the QUEST conference with the two founders of Selenium: Jason Huggins of Sauce Labs and Simon Stewart of Google.
Before the panel started we chatted a bit with the moderator. We couldn’t come up with…

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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The draft guidance defines when mobile platforms are considered as part of a regulated system or not.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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