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 compliant with the standard from the International Organization for Standardization...