Shuwen Biotech receives EN ISO 13485 certification

Shuwen Biotech Co. Ltd, a China-based diagnostic company focused on licensing, developing and commercialising diagnostic kits and services for unmet clinical needs, announced that it has received EN ISO 13485 certification

The EN ISO 13485 quality management system certification ensures the good manufacturing of IVD kits, in compliance with the internationally recognised ISO 13485 standards.

“As a diagnostic kit manufacturer, we strive to meet the internationally recognised standards,” said Jay Z. Zhang, Chairman and CEO of Shuwen Biotech Co. Ltd.

“The ISO 13485 certification is a major boost for executing our licensing and international partnership strategies. It not only ensures that we make high quality IVD kit products for the Chinese market based on licensed technologies, but also enables us to manufacture IVD kit products for our partners in Europe and other parts of the world, which provides an alternative low cost and high quality manufacturing base for our partners.”