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U.S. Devicemakers Make Four Errors on Compliance With EN ISO 14971:2012

November 1, 2013
Many U.S. devicemakers are falling short of compliance with EN ISO 14971:2012 during their EU inspections because of four critical mistakes, an expert says. The standard, which relates to risk management, replaced an earlier version in 2012. While the normative section of the standard is identical, the 2012 version includes the “Annex Zs” — ZA, ZB and ZC, Ibim Tariah, technical director for BSI Healthcare Solutions, said.
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