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.