BGI has invested heavily in R&D and innovation of new sequencing devices, including an independent IT platform which provides professional and easy-to-use biometric information cloud services for research institutions, hospitals and other users. BGI has also certified some products internationally. The HPV genotyping test kit (semiconductor sequencing method) and the amino acid and carnitine detection kit (liquid chromatography-tandem mass spectrometry) developed by BGI have obtained a CFDA medical device registration certificate. BGI Europe A/S obtained a CE certification for in vitro diagnostic medical devices and can now be marketed within the EU. As to quality management of medical devices, several subsidiaries have obtained ISO 13485 certification.

China Bio news release, May 22, 2018