WuXi Biologics (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), announced that it has successfully achieved ISO 13485:2016 Medical Device Quality Management System certification with zero non-conformities, becoming among the first in China's drug-device combination products sector to obtain this certification. The achievement highlights the company's robust quality system and strong compliance capabilities, reflecting a solid foundation for delivering safe, stable and reliable end-to-end services to clients worldwide.

ISO 13485:2016 is widely recognized as the global gold standard for quality management in the medical device industry. It provides a structured framework to ensure safety, effectiveness and regulatory compliance across the full product lifecycle. The standard spans core elements — such as design and development, risk management, manufacturing process control, traceability, and supplier management — and emphasizes alignment with applicable regulatory requirements. Given the cross-disciplinary nature of drug-device combination products, their development and manufacturing must meet both the stability requirements for active pharmaceutical ingredients and the performance requirements for medical devices. Building on its existing cGMP framework, WuXi Biologics established a combination-product system that is aligned with both pharmaceutical and medical device regulatory expectations.

During the nearly five-day on-site audit, WuXi Biologics demonstrated a strong systems foundation and a comprehensive quality management approach for drug-device combination products, successfully obtaining certification and proving the robustness of its platform for commercial manufacturing.

Dr. Chris Chen, CEO of WuXi Biologics, commented, "Successfully achieving ISO 13485 certification reflects our technical depth and disciplined quality management for drug–device combination products. We will continue to uphold rigorous quality standards and reliable operations to deliver safe, efficient and high-quality solutions for global clients, empowering the development of breakthrough therapies through a trusted CRDMO platform."

WuXi Biologics has continuously strengthened its sustainability and compliance management systems, building an integrated framework that encompasses information security, business continuity, quality management, environmental and occupational safety, energy management, and sustainable procurement. The company has obtained multiple internationally recognized certifications — including ISO/IEC 27001, ISO 22301, ISO 9001, ISO 14001, ISO 45001, ISO 50001, ISO 14064 and ISO 20400 — that verify the strength of WuXi Biologics' foundation for high-quality and sustainable growth.