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GHTF/ISO Agreement Allows Greater Regulatory Input On ISO 9001 Revision

This article was originally published in The Gray Sheet

Executive Summary

A memorandum of understanding (MOU) between the Global Harmonization Task Force and Technical Committee 210 of the International Organization for Standardization (ISO) will allow task force members to participate in TC 210's planned revision of ISO's medical device-specific quality systems standards (ISO 13485 and 13488).
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