PolyVation was audited in November 2021 for certificate renewal of its ISO 13485:2016 quality management system. The extensive audit took 3 full days. We again passed the audit with great success, without any findings, and received the certificate. PolyVation is certified for compliance with the ISO 13485:2016 standard with the scope: "Design and development, analysis, testing and custom manufacturing of polymers for medical and pharmaceutical applications". We are very proud to be certified for ISO 13485 since 2010 and to be one of the first biomaterials company in the world with such certification for such a long time. Quality is a process of continuous improvement, and this illustrates the high level at which we operate. We believe that quality is instrumental in getting groundbreaking innovations in medicine to the patient and this is what drives us each day.