ISO 13485

The ISO 13485 standard concerns producers and suppliers of 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.


Benefits of 13485 certification:

  • 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


Certified organisations can include RFTC certification logos in their promotional activities.