We Are Now ISO 13485:2016 Certified!

We are proud to announce that we have been awarded ISO 13485:2016 and JIS Q ISO 13485:2018 certifications from TÜV Rheinland LGA Products GmbH (TRLP). These certifications indicate that our quality management system maintains stringent international standards for medical devices, including in vitro diagnostic assays.

To be certified ISO 13485, our materials, processes, products and services underwent rigorous and independent testing for safety, product performance or reliability. Specifically, the scope of the certifications covers:

•    Manufacturing and distribution of buffers and molecular diagnostic reagents for the use in in vitro diagnostic medical devices

•    Provision of standard and customised services for:

     -DNA Sanger Sequencing

     -Fragment Analysis

     -Next-Generation Sequencing and

     -Other molecular biology services for in vitro diagnostic medical devices

Download PDF for our ISO 13485:2016 certification.