Published in 2016, ISO 13485 is the international standard for quality management systems for the medical device sector. The regulation is designed to work efficiently and transparently with other management systems across the world.
The FDA’s decision to use ISO 13485 is another step in helping the standard gain global recognition.
Wil Vargas of the Association for the Advancement of Medical Instrumentation (AAMI), and secretary of ISO/TC 210 – the committee responsible for aspects of medical devices, said: “This announcement will take global harmonisation of regulatory requirements in the medical devices sector to a next level”.
The committee chair, Peter Linders, added: “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”.