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FDA: Some Companies Having Trouble Performing Design Control Activities

This article was originally published in The Silver Sheet

Executive Summary

DESIGN CONTROL CAN PROVE PROBLEMATIC for medical device manufacturers that don't have highly skilled engineers on staff, says CDRH official Al Taylor, speculating that firms that skimp on engineering resources may have played a role in last year's increase in design control citations on FDA warning letters. In particular, FDA has found that manufacturers are struggling with design verification, design validation and design change activities, FDA GMP Expert Kim Trautman says. She adds that last year's jump in recalls suggests that firms aren't “doing the amount of work that [they] need to in this area.” Meanwhile, device manufacturers Thoratec, Philips Consumer Healthcare Solutions and Hitachi Chemical Diagnostics share best practices for design control.

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