ISO 13485:2016Medical devices — Quality management systems — Requirements for regulatory purposes, is the International Standard for quality management systems for the medical devices sector. Published in 2016, it is designed to work with other management systems in a way that is efficient and transparent. The standard, which is now in its third edition, received strong support from the FDA, in line with its drive for global convergence of medical device regulatory processes.

The announcement by the FDA that it will use ISO 13485 in replacing its current quality system regulation, is an important next step in the recognition this standard has already gained globally.

ISO/TC 210 warmly welcomes the FDA’s planned adoption. This ISO technical committee, responsible for the quality management and corresponding general aspects for medical devices, is run by ANSI, ISO’s member in the United States.

Wil Vargas of the Association for the Advancement of Medical Instrumentation (AAMI), and Secretary of ISO/TC 210, said “this announcement will take global harmonization of regulatory requirements in the medical devices sector to a next level”. The committee Chair, Peter Linders, added that “this bold step by the FDA seems logical, considering the role of ISO 13485 as the foundation for the Medical Devices Single Audit Program (MDSAP), currently operated by Australia, Brazil, Canada, Japan and the USA”

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