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On March 28, 2025, Bozhou Rongjian Medical Appliance Co., Ltd. officially obtained the ISO 13485:2016 certification for medical device quality management systems, marking a significant milestone in our pursuit of internationally recognized standards in medical device manufacturing.

 This certification, an important milestone for the medical device industry, involved a rigorous audit conducted by an internationally recognized certification body. It comprehensively covered the company’s R&D, production, sales, and after-sales service processes. Key aspects such as quality policy, risk management, and process control were thoroughly evaluated, ultimately confirming that Rongjian Medical's quality management system fully complies with the international “gold standard” in the medical device sector.

Obtaining the ISO 13485 certification is not only an acknowledgment of our current quality management system, but also a new starting point for continuous improvement. We will take this opportunity to further enhance our end-to-end quality control system — from raw material sourcing to final product delivery — to provide safer and more reliable medical products to customers worldwide.