About Us
Committed to the creation, invention to produce high quality medical products
Quality Control
Quality Management System Certification
Core Standards:Strictly follows ISO 13485 Medical Devices Quality Management System and YY/T 0287 Medical Device Production Quality Management Specifications, covering the entire process from research and development, production, testing to sales.
Domestic Certification:Holds domestic Class I and Class II medical device product registration certificates and Class II production licenses, ensuring the products are legally and compliantly marketed.
Clinical Verification:Through cooperation with provincial and ministerial hospitals, clinical effect tracking of products is carried out to optimize design flaws (such as verification of the drainage rate of negative pressure drainage devices).
Production Process Control
Raw Material Management
Medical polymer materials (such as silicone and polyurethane) must pass supplier qualification audits and undergo biocompatibility tests (such as cytotoxicity and sensitization tests) in the physical and chemical laboratory.
Process and Automation
Interventional catheter products adopt precision extrusion molding technology. The diameter and wall thickness are controlled by automated equipment, with an error range of ≤ ±0.05mm.
An intelligent warehousing system is introduced to achieve material traceability (such as batch number management) and prevent cross-contamination.
Sterilization and Packaging Verification
The sterilization process must pass bioburden testing and sterility assurance level (SAL ≤ 10⁻⁶) verification, and the packaging seal test conforms to the GB/T 19633 standard.
Product Testing and Continuous Improvement
Factory Inspection Items:Including physical properties (such as tensile strength), functional tests (such as the one-way valve sealing performance of negative pressure drainage devices) and sterility tests, with a qualification rate of ≥99.5%.
Quality Traceability:The production batch, operators and test data are recorded through the ERP system to achieve rapid recall and analysis of problematic products.
Industry-Academia-Research Collaboration:Cooperating with institutions such as the Three Gorges University to develop new technologies (such as antibacterial coating catheters) and optimize product design through clinical feedback.
Official website
Business consulting
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