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China Medical Device Industry Yearbook - 2017  (the Fourth Edition)


China Market for Color Ultrasound Equipment

Shuwen Biotech Receives EN ISO 13485 Certification
  Shuwen Biotech Co. Ltd.   January 17, 2017

Shuwen Biotech Co. Ltd., a China-based diagnostic company focused on licensing, developing and commercializing 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 recognized ISO 13485 standards.

“As a diagnostic kit manufacturer, we strive to meet the internationally recognized 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.”

About Shuwen Biotech Co. Ltd.


Based in China and led by U.S. diagnostic industry veterans, Shuwen Biotech is an integrated diagnostic company engaged in licensing, developing, marketing and distributing innovative products and services for disease diagnosis and personalized medicine. The company strives to provide doctors and their patients with a comprehensive menu of the most innovative diagnostic products and services for improved disease prediction, screening, diagnosis, prognosis and treatment. Shuwen offers diagnostic kits and diagnostic services for disease prevention and personalized medicine in cancer and other diseases.

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Shuwen Biotech Co., Ltd.
Grace Lou



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