Dear partners and clients!
We are glad to announce that our company has received the ISO 13485:2016 international quality certificate for medical devices/materials.
Safety and quality are “non-negotiable issues” in the field of medical devices/materials. Regulatory requirements are becoming more stringent throughout the entire product lifecycle, including lifetime and delivery.
Our company demonstrates quality management processes and ensures that it follows the best practices in what it does.We supply zirconia CAD/CAM blanks that meet both customer requirements and the requirements applicable to these medical devices/materials.
The ISO 13485:2016 standard for medical quality management systems is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical industry.
We once again confirmed the qualification and compliance of the production process of zirconia blanks for CAD / CAM systems, namely our ZICERAM brand, with safety and quality requirements in addition to the previously received GOST ISO 13485:2017 certificate.