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QUOTED. 11 September 2019. Kim Trautman.

Executive Summary

A new Technical Information Report (TIR) from the Association for the Advancement of Medical Instrumentation (AAMI) compares regulatory requirements found in the US FDA's Quality System Regulation to those in international standard ISO 13485 – and vice versa. See what Kim Trautman, who authored the QSR in the 1990s, said about the report here.

"[AAMI TIR102:2019] is an officially recognized mapping tool for the medical device global industry. The mapping tool is bi-directional to assist in identifying the regulatory requirements in [the] Quality System Regulation to be addressed through an ISO 13485-compliant QMS [quality management system]." – Kim Trautman, executive VP of medical device international services, NSF International

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