ISO 13485 - Quality Management System for Medical Devices


A certificate issued by an independent, accredited certification body guarantees that a quality management system has been implemented, documented, used, maintained and improved by the supplier or producer of medical devices.


The ISO 13485 standard concerns producers and suppliers of medical devices.

Certified organisations can promote themselves as certificate holders in their promotional materials and can include the URS certification logo free of charge.

Why ISO 13485 - Quality Management System for Medical Devices?
  • guarantees high quality of provided services and products
  • reduces production loss rate
  • reduces operational costs
  • increases effectiveness across the whole organisation
  • increases your customers‘ trust in you as a safe supplier or producer

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