WuXi Biologics Garners ISO 13485 Certification for Drug-Device Combination Product Manufacturing

WuXi Biologics has achieved International Organization for Standardization (ISO) 13485:2016 Medical Device Quality Management System certification with zero non-conformities. The designation certifies WuXi’s fitness for commercial manufacturing and quality management of drug-device combination products.

Among the First in China

ISO 13485:2016, a framework to ensure safety, effectiveness, and regulatory compliance, is recognized as the gold standard for quality management. WuXi Biologics hosted a multi-day audit during which the company had to demonstrate the robustness of its systems foundation.

Subsequently, it is now among the first companies in the drug-device combination product sector in China to mark this milestone.

“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.”

WuXi Biologics says it built upon the company’s existing current good manufacturing practice framework to establish its combination-product system. According to the company, this aligned the system with pharmaceutical as well as medical device regulatory requirements.

Not WuXi’s First ISO Certification

Such requirements are key components of ISO 13485:2016, along with risk management, supplier management, manufacturing process control, and traceability.

This latest ISO certification is one of more than a half-dozen WuXi Biologics has secured for quality and sustainable growth. The global CRDMO offers end-to-end solutions, supported by 13,000-plus employees in China, the U.S., Ireland, Germany, and Singapore.

As of December 2025, WuXi Biologics was supporting nearly 1000 integrated client projects, more than half in complex modalities. These included 74 projects advancing to Phase III, plus 25 in commercial manufacturing.