From the January 2007 issue of "The Silver Sheet"
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.
This article continues in the January 2007 issue of "The Silver Sheet"
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Also covered in this issue:
TRENDS FACING THE DEVICE INDUSTRY IN 2007 include greater FDA enforcement of outsourcing controls and a continued focus on postmarket issues, experts predict.
WARNING LETTERS: Welch Allyn company MRL Inc. cited for QS and MDR violations.
IN BRIEF: GE subsidiary signs consent decree and is blocked from selling X-ray devices; GAO report explains why manufacturers are shying away from FDA’s AP inspection program.
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