ISO 13485:2016 – Medical devices

ISO 13485 Certification of quality management system for design and manufacture of medical devicesA 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.Benefits of ISO 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 promote themselves as certificate