Standards
International standard for quality management systems for medical devices. Required by EU MDR.
The standard is ISO 13485:2016, “Medical devices — Quality management systems — Requirements for regulatory purposes”, third edition, published March 2016. ISO describes it as “the internationally recognized standard for quality management systems in the design and manufacture of medical devices”, setting requirements so manufacturers “ensure their medical devices meet both customer and regulatory demands for safety and efficacy”. The subtitle is the point: unlike ISO 9001, this one exists to satisfy regulators, which is why device authorities across markets lean on it.
ISO’s own catalogue description. The standard’s text is a paid publication and is not quoted here.
From the AJG lexicon archive (July 2026).
Developed by Amit Jain at allfrontierglobal.com
© 2026 All Frontier Global · Panchkula, Haryana, India
Developed by Amit Jain at allfrontierglobal.com · purposed.in · purposed · purposed2 · merchcomp.com · uuka.org
Compiled reference — verify current specifics at the source.
A question, a correction, or something you'd like covered. It goes straight to his inbox — no list, no newsletter.