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.