ISO 13485:2016

ISO 13485 is an internationally recognized standard that defines the requirements for a quality management system specifically tailored to organizations involved in the design, development, production, installation, and servicing of medical devices.
The standard ensures that medical device manufacturers consistently meet customer expectations and comply with stringent global regulatory requirements by emphasizing risk management, traceability, documentation control, and continuous oversight throughout the entire product lifecycle.
Unlike the more general ISO 9001, ISO 13485 incorporates additional, industry‑specific criteria to assure the safety, effectiveness, and reliability of medical devices across all stages of manufacture and supply.