9. 通過 ISO 13485：2016 醫療器材品質管理系統認證
Passed ISO 13485：2016 medical device quality management system certification
CytoAurora Biotechnology officially passed the ISO 13485:2016 audit certification on March 8, 2022. From the establishment of the quality system, to the management of product production processes, various audits and management reviews, through the implementation and cooperation and efforts of our colleagues, we finally successfully passed various assessments and obtained certificates, ensuring that the company's production and service quality are in line with International standards and specifications.
Since its establishment in 2015, CytoAurora Biotechnology has continuously worked hard in the field of biomedicine, integrating semiconductor technology, artificial intelligence, automated machinery, molecular biology and other professional technical fields, and independently developed and manufactured products with high sensitivity, high specificity and high capture rate. Medical diagnostic equipment: Cell Reveal system, as a new generation of CTC medical testing platform leading global technology, can not only be widely used in early cancer screening, auxiliary diagnosis, treatment effect evaluation, but also can be used with genetic testing technology to complete gene amplification Increase various genetic research and medical application fields such as targeted drug companion genetic diagnosis.
This certification is just a small step on our journey to challenge the world's top. CytoAurora Biotechnology will continue to uphold the original intention of quality first, lead the development of global medical testing technology and cell research technology, and continue to pursue excellence and progress.