ISO 13485 CERTIFICATION

The ISO 13485 standard "Medical devices -- Quality management systems -- Requirements for regulatory purposes" in Italian "Dispositivi medici - Sistemi di gestione per la qualità - Requisiti per scopi regolamentari" identifies a standard for the specific quality management system for medical companies, which includes aspects of the ISO 9001 standard and specific requirements for the medical device industry.

The ISO 13485 standard is certifiable, i.e. it is possible to obtain certificates of conformity with the requirements contained therein from an accredited certification body that operates within certain rules.