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Meet MAUDE

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FDA Guidance Advises Device Makers to Think About Home Use

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FDA Lets MDDS Off the Regulatory Hook

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Validating for Success

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World Health Assembly 2014

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FDA Issues Final Guidance on Expedited Drug Approvals

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Is Your Medical Device ‘State of the Art?’

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Yes
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Not knowing the answer to the question posed in the title of this article has led many medical device manufacturers to undertake expensive and unnecessary retesting of their previously certified products.

Recipe for Success: Food Safety Regulations and the Role of Quality Management

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Editor’s note: A webinar on this topic will held on May 29, 2014, at 2:00 p.m. Eastern / 11:00 a.m. Pacific. Register here.

What Kind of Fish Is That?

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Have you sometimes wondered if that “wild caught” salmon actually came from an aqua farm? Or if the “U.S. catfish” in the display case might have been born and raised in Vietnam? Is that “red snapper” actually red snapper and worth the premium price?

Interpreting the FDA View of Medical Device Design Controls

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Pagination

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