WuXi Biologics has obtained ISO 13485:2016 Medical Device Quality Management System certification, following an on-site audit that concluded with zero non-conformities. The company is among the first in China’s drug–device combination product sector to receive this certification, which covers its development and manufacturing activities for such products.
ISO 13485:2016 is an internationally recognized standard for quality management systems in the medical device industry. It provides a framework to support safety, effectiveness and regulatory compliance across the product lifecycle, including design and development, risk management, manufacturing process controls, traceability and supplier management. Drug–device combination products must satisfy requirements for both active pharmaceutical ingredients and medical devices, and WuXi Biologics has built this system on top of its existing cGMP framework to align with both pharmaceutical and device regulatory expectations.
The certification audit, which lasted nearly five days, assessed WuXi Biologics’ systems and processes related to drug–device combination products. The company reported that successfully completing the audit and achieving certification demonstrates the robustness of its platform for commercial manufacturing in this area. WuXi Biologics stated it plans to maintain stringent quality and operational standards as it provides end-to-end services for global clients developing combination products.