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Too Late for a QMS: Theranos' Ignoring FDA Compliance Will Cost it Billions

[fa icon="calendar'] Sep 1, 2016 3:46:59 PM / by Pat Flanders posted in Quality & Compliance, Audit, Certification

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Theranos, the once-hot clinical testing start-up, has taken a beating in the press recently. With almost $700 million in venture funding and buttressed by promises of dramatically new and better ways of testing blood samples, the company was once poised to be a model for life sciences companies of the future. Agile and smart, Theranos rapidly moved into a huge market on the back of its proposed innovative solutions.

"...given the amount of scrutiny they're under, I would have expected them to be particularly careful about the regulatory issues surrounding research on human subjects."

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