FDA FastStats: A Look Back at 2013 Medical Device Warning Letters with Quality System Deficiencies

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FDA FastStats: A Look Back at 2013 Medical Device Warning Letters with Quality System Deficiencies: In our latest infographic analysis, today’s post highlights medical device warning letters with quality system deficiencies. Surprisingly, warning letters were actually down 12.2% from 2012. However, they are almost double the number (77) issued in 2009. Are we looking at a downward trend? The jury’s still out. The highest number of warning letters issued in the past 10 years was in 2012, with a total of 164. The lowest was 2007, with only 74 warning letters issued.

FDA FastStats 2013 - Medical Device Warning Letters

 

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FDA FastStats: Device Warning Letters with Quality System Deficiencies
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FDA FastStats: Device Warning Letters with Quality System Deficiencies
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Medical device warning letters with quality system deficiencies were actually down 12.2% from 2012 but almost doubled the number issued in 2009
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AssurX
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Quality Management Software
AssurX Quality + ComplianceA single versatile software system can improve quality, compliance and streamline workflow.
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Quality Management Software
AssurX Quality + ComplianceA single versatile software system can improve quality, compliance and streamline workflow.