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

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.