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International News In Brief

This article was originally published in The Gray Sheet

Executive Summary

Quality systems technical report: Final version of Technical Report 14969, which provides guidance on device use quality systems standard ISO 13485:2003, is expected by late spring or early summer, BSI Assistant VP-Product Services Paul Brooks tells participants at Regulatory Affairs Professionals Society Principles & Practices of EU Regulatory Affairs meeting Feb. 23-24 in Arlington,Va. TR 14969 previously was a guidance standard, but was changed to a technical report with the update of ISO 13485 (1"The Gray Sheet" July 2, 2001, p. 14). The ISO quality standard will replace its 1996 predecessor in July 2006...

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