WuXi Biologics has achieved ISO 13485:2016 certification, a globally recognized standard for medical device quality management systems. The company cleared the audit with zero non-conformities, underscoring the strength of its quality framework and manufacturing capabilities.
WuXi Biologics becomes one of the first companies in China’s drug-device combination product space to earn this certification. The process involved a comprehensive multi-day audit, where the company demonstrated the effectiveness and reliability of its operational systems.
“Successfully achieving ISO 13485 certification reflects our technical depth and disciplined quality management,” said WuXi Biologics CEO Chris Chen, PhD. “We will continue to uphold rigorous quality standards and reliable operations to deliver safe, efficient and high-quality solutions.”
According to WuXi Biologics, it developed its new system by expanding on its existing manufacturing practices. This approach allows the company to synchronize its operations with both pharmaceutical and medical device regulatory standards simultaneously.
Expanding Established Quality Portfolio
Key elements of ISO 13485:2016 include risk management, supplier oversight, manufacturing process control, and full product traceability – areas that form the backbone of a robust quality management system.
This certification is one of several ISO standards WuXi Biologics has achieved, reflecting its continued focus on quality and sustainable growth. As a global CRDMO, the company delivers end-to-end solutions backed by a workforce of over 13,000 employees across China, the United States, Ireland, Germany, and Singapore.
As of December 2025, WuXi Biologics was supporting nearly 1,000 integrated client projects, with more than half involving complex modalities. These include 74 projects in Phase III development and 25 in commercial manufacturing, highlighting the company’s strong presence across the product lifecycle.
Overall, the certification further strengthens WuXi Biologics’ position as a key player in the global drug-device combination market.
