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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


醫華生技已於2022年3月8日,正式通過ISO 13485:2016稽核認證。從品質系統建置,以及管理產品生產流程、各項稽核與管理審查,經過本公司同仁們的落實配合與努力,最終順利通過各項考核並取得證書,確保本公司的生產與服務品質,符合國際標準規範。

從2015年創立至今,醫華生技在生醫領域不斷努力,整合了半導體技術、人工智慧、自動化機械、分子生物等專業技術領域,自行開發與製造具有高靈敏度、高特異性、高捕獲率的醫療診斷儀器:Cell Reveal系統,作為領先全球技術的新一代CTC醫學檢測平台,不但可廣泛應用於癌症早期篩查、輔助診斷、治療效果評估、更可以用於搭配基因檢測技術,完成基因擴增以及標靶藥物伴隨式基因診斷等各項基因研究與醫學應用領域。


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.

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