Posts Tagged ‘FDA Validation’
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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In every software project where I’ve used some form of review process (formal inspections, walkthroughs, or reviews – for this post I refer to all as “reviews”), the gain has always justified the pain. Invariably, some developers really dislike this process, leading to tantrums reminiscent of Orange Country Choppers.
But I’ve regretted every time…
Read MoreThe 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The draft guidance defines when mobile platforms are considered as part of a regulated system or not.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…
Read MoreA 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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