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Articles tagged FDA guidance

A Critical Analysis of FDA Guidance for User Percentile Device Design Criteria Versus Currently Available Human Factors Engineering Data Sources and Industry Best Practices

  A staggering report was recently released by the International Consortium of Investigative Journalists (ICIJ) indicating that 83,000 deaths and 1.7 million injuries were linked to medical device adverse events reported over the last decade. Furthermore, a 2013 report by McKinsey & Company suggested that such adverse events and associated quality issues cost the medical … Continue reading A Critical Analysis of FDA Guidance for User Percentile Device Design Criteria Versus Currently Available Human Factors Engineering Data Sources and Industry Best Practices

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