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FDA's Quality System Regulation Is Mapped To International Standard ISO 13485 – And Vice Versa – In New Report From AAMI

 
• By Shawn M. Schmitt

A new Technical Information Report (TIR) from the Association for the Advancement of Medical Instrumentation compares regulatory requirements found in the US FDA's QSR to those in quality systems standard ISO 13485:2016. While the 146-page document is aimed at US device-makers, it could also be helpful to the FDA as the agency works to harmonize its QSR with the ISO standard.

QSR-ISO_193503416

A new Technical Information Report (TIR) from the Association for the Advancement of Medical Instrumentation (AAMI) compares regulatory requirements found in the US Food and Drug Administration's Quality System Regulation to those in international standard ISO 13485 – and vice versa.

AAMI TIR102:2019, released on 30 August, aims to help befuddled US device-makers that operate under the QSR ensure they're...

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