Recently, Bondex Medical Management (Shanghai) Co., Ltd. (hereinafter referred to as "Bondex Medical") announced its successful attainment of the globally recognized ISO 13485 certification for medical device quality management systems. This milestone not only highlights the company’s commitment to excellence in the medical device supply chain sector but also solidifies its foundation for expanding into global markets.
1. ISO 13485: A Benchmark of International Trust
The ISO 13485 certification, one of the most stringent quality management standards in the global medical device industry, covers the entire lifecycle of medical devices—from design and development to production, distribution, and post-market services—with a strong emphasis on risk management and regulatory compliance. During the audit process, Bondex
Medical demonstrated a highly standardized quality management system, rigorous mechanism of risk controls and operational workflow optimization, achieving zero major non-conformities and passing the assessment with distinction.
This internationally recognized qualification not only paves the way for the company's business internationalization but also provides clients with highly reliable and compliant
medical device supply chain solutions.
2. GSP Certification: Safeguarding Safety and Compliance in Medical Distribution
In addition, Bondex Medical holds the Good Supply Practice (GSP) certification, a critical credential in medical product circulation. This certification guarantees full-process control and safety in procurement, storage, and transportation. By adhering to GSP standards, Bondex Medical has implemented end-to-end refined management across multimodal logistics (sea, air, rail) and integrated customs affairs, warehousing and distribution. This ensures traceability and security for high-value products such as medical devices and in vitro diagnostic reagents, helping clients mitigate operational risks and enhance market competitiveness.
3. One-Stop Medical Supply Chain Services: Comprehensively Empowering Clients
As a subsidiary of Bondex Supply Chain Management Co., Ltd. (Stock Code: 603836), Bondex Medical leverages its parent company’s robust logistics expertise to deliver comprehensive, professional one-stop supply chain services for the healthcare industry.
Our core services include:
• Specialized Medical Product Warehousing & Cold Chain Logistics
• Cross-Border Customs Clearance & Bonded Services for Medical Devices
• Global Logistics Network Supporting International Expansion
• Digitalized Transparent Supply Chain Management with real-time tracking and intelligent alerts
4. Our Commitment: Your Success is Our Success!
Bondex Medical remains client-centric, continuously elevating service quality and efficiency. We look forward to collaborating with partners in the medical device industry, sharing professional advantages, and co-creating a brighter future for healthcare!
