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How Far is Possible for Risk Management

ISO 14971 is the risk management standard for medical devices. FDA and Health Canada have recognized the 2007 version of this international standard, but the European Commission has identified 7 deviations from the Essential Requirements of the European Medical Device Directives. These deviations are identified in Annex ZA of EN ISO 14971:2012.

In this article, authors Rob Packard and Erik Vollebregt examine Deviation No. 3, Risk reduction "as far as possible" vs. "as low as reasonably practicable." How should manufacturers comply?

Read their recommendations in BONEZONE®, June 2014.

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