MRA Set For Baseline Activation: Niedelman Contrasts ISO, QSIT Approaches
This article was originally published in The Gray Sheet
Executive Summary
A delegation representing U.S. interests in the U.S./EU mutual recognition agreement is meeting with the European Commission in Brussels to discuss progress on U.S. conformity assessment bodies (CABs)
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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...
International News In Brief
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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