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Draft Revision Of Risk Management Standard Gives Firms More Guidance

This article was originally published in The Silver Sheet

Executive Summary

MANAGERS AND EMPLOYEES RESPONSIBLE FOR RISK MANAGEMENT will soon gain updated guidance, thanks to a revision of ISO 14971, the voluntary international standard that explains how to manage medical device risk. While the changes offer new insights for all companies, manufacturers of in vitro diagnostic devices could benefit most from the expanded standard, says FDA’s Bill Midgette... TRENDS FACING THE DEVICE INDUSTRY IN 2007 include greater FDA enforcement of outsourcing controls and a continued focus on postmarket issues, experts predict...

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Benefit-Risk Is Front-And-Center In Latest Revision Of International Risk Management Standard ISO 14971





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