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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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The International Organization for Standardization (ISO) has strengthened benefit-risk language in the latest redo of ISO 14971, the voluntary standard that instructs device-makers on how to best put together a risk management program. Regulators – including US FDA – are increasingly considering benefit-risk when weighing product availability and regulatory compliance issues. And Jos Van Vroonhoven, convener of a joint working group that revised the standard, says a more global regulatory emphasis on risk management and a desire to clarify the document in general led ISO to revise the standard. Also: Van Vroonhoven identifies four updated clauses in the revamped standard that firms should keep a sharp eye on.

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