- WuXi Biologics has achieved ISO 13485:2016 certification for its medical device quality management system with zero non-conformities.
- The certification supports the company’s capabilities in drug-device combination product development and manufacturing.
WuXi Biologics has announced that it has achieved ISO 13485:2016 certification for its medical device quality management system, with zero non-conformities identified during the audit. The certification positions the company among early adopters in China’s drug-device combination products sector and reinforces its contract manufacturing and development capabilities.
The ISO 13485:2016 standard is recognized globally for quality management in the medical device industry, covering areas such as design and development, risk management, manufacturing process control, and supplier oversight. WuXi Biologics stated that it has aligned its systems to meet both pharmaceutical and medical device regulatory requirements for combination products.
The certification followed a nearly five-day on-site audit, during which the company demonstrated its quality management systems and manufacturing processes for drug-device combination products. The company noted that this achievement supports its ability to deliver compliant and consistent services for global clients.
WuXi Biologics has integrated its combination-product system with its existing cGMP framework to support end-to-end services across development and commercial manufacturing. The company indicated that its platform is designed to meet the requirements of both active pharmaceutical ingredients and medical device components.
“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.”
Dr. Chris Chen, CEO of WuXi Biologics
