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Firms Take Second Look At Risk Management Following High-Profile Recalls

This article was originally published in The Silver Sheet

Executive Summary

RISK MANAGEMENT ACTIVITIES ARE RECEIVING CLOSER SCRUTINY as FDA and device companies renew their focus on product safety in the wake of Guidant’s devastating series of recalls earlier this year. Risk analysis is required by the design control section of the Quality System Regulation and is "envisioned to be an inherent part of the decision process" throughout the rule, CDRH compliance director Tim Ulatowski reminds firms. FDA investigators may examine risk management practices while inspecting either design control or CAPA systems, experts note. Companies can ensure their activities are up to par by following the recommendations in ISO 14971, the international standard on the application of risk management to medical devices...
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