Runbio established a quality management system in June 2007. We obtained the ISO13485:2003 QMS certificates from TUV inJuly 2010 and successfully passed the annual audit from then on. Besides, our QMS also meets MDSAP requirements. Our facility has been registered in the USA and passed the FDA inspection in September 2010. But beyond that our QMS also meets relevant requirements of CE regulations and obtained MDSAP QMS certificate from TUV in 2018. In 2010 and 2019, we passed CE registration review by TUV and obtained several CE certificates for list B and self testing products.

2018 ISO_页面_1.jpgcert 16807002.001(毒品-1)2017.12.21-2022.12.20(1).jpgLH-HCG-FSH 产品证书(CE2015版).jpg