Preparing For A US Medical Device Inspection - The Need For Speed
This article was originally published in SRA
Executive Summary
Given that US Food and Drug Administration inspectors preannounce around 86% of the domestic medical device facility inspections they conduct, it's difficult to imagine that manufacturers could be caught unprepared – yet many do not have the appropriate records ready for investigators when they knock on the front door, reports Shawn M Schmitt.
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