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Yanwei Technology (Shanghai) Co., Ltd. is an integrated technical service enterprise focusing on supporting the medical device industrial chain, integrating medical device testing, process validation, technical consultation and compliance guidance. We serve industries including medical equipment, interventional & implantable devices, aesthetic instruments and IVD products, providing full-cycle compliance technical support for medical manufacturers.
We run standardized testing laboratories fully equipped with complete testing equipment for physical & chemical analysis, microbiology, sterility and EO sterilization validation. Our experienced technical team is well-versed in medical regulatory standards of NMPA, FDA, CE and other global authorities. Our core services include sterilization process development, EO validation, biocompatibility testing, package integrity testing, registration dossier compilation, on-site inspection coaching, quality system establishment, internal audit and annual compliance maintenance.
Based in Shanghai’s industrial cluster, we deliver customized solutions for medical manufacturers across the Yangtze River Delta and nationwide, covering R&D trial production, registration filing, mass production quality control and post-market compliance management. We help enterprises resolve registration and process challenges to accelerate compliant commercialization of medical products.