Beijing Huakang Tianyi has established a comprehensive quality inspection system with an independent quality testing center, equipped with automated CMMs, universal mechanical testing machines, metallographic microscopes and spectrometers — covering full-process quality control from raw material incoming to finished product outgoing.
Strictly following ISO 13485 medical device quality management system requirements, we implement a three-level inspection system (IQC, IPQC, FQC) to ensure dimensional accuracy, mechanical properties, surface quality and biocompatibility fully comply with national standards and industry specifications.
Max Dimensional Accuracy
Critical Dimension Full Inspection
Precision Testing Equipment
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Major Quality Incidents
Regulations as foundation, pursuing excellent quality, creating healthy lives — every product undergoes strict inspection, every process is traceable.
Imported high-precision coordinate measuring machine for fully automated precision measurement of complex 3D curved surfaces, comprehensively verifying geometric dimensions and form tolerances of acetabular cups, femoral stems and other products.
High-resolution automated optical vision measuring system with 2D/3D measurement capabilities, quickly detecting product contours, hole diameters, angles and other 2D dimensions for batch rapid inspection.
Computer-controlled electro-hydraulic servo universal testing machine for tensile, compression, bending and fatigue mechanical property testing, verifying implant mechanical strength and fatigue life.
High-precision contact-type roughness and profile measuring instrument for surface roughness Ra, Rz and profile shape measurement, ensuring articulating surface quality meets medical implant requirements.
High-magnification metallographic analysis microscope with sample preparation equipment for observing metal material microstructure, grain size and inclusions, monitoring raw material quality and heat treatment process stability.
Direct-reading spectrometer for rapid and accurate chemical composition analysis of titanium alloy, CoCrMo and other medical metal materials, ensuring raw material grades and composition meet ASTM/ISO international standards.
Equipped with particle counters and microbial samplers for clean environment monitoring, regularly testing production workshop and testing environment cleanliness to ensure Class 10,000 clean rooms remain compliant.
Rockwell/Vickers hardness testers and coating thickness gauges for monitoring product heat treatment hardness and surface coating thickness, ensuring wear resistance and service life.
Established sterility testing room and packaging validation laboratory for sterility inspection and packaging integrity testing of sterilized products, ensuring products remain sterile within shelf life.
Raw material certificate and batch verification
Spectral analysis for material chemical composition
Dimensional and visual full or sampling inspection
Microstructure and hardness testing
Non-conforming product isolation and supplier traceability
First-article CMM full-dimension measurement confirmation
Inter-process patrol inspection and SPC statistical process control
Real-time monitoring and recording of critical process parameters
Semi-finished product flow identification and status management
Abnormal shutdown handling and corrective/preventive actions
Finished product full-dimension CMM re-measurement
100% surface roughness and visual inspection
Mechanical property and fatigue sampling testing
Labeling, packaging and sterilization efficacy validation
Product release review and traceability records
Full-process quality traceability, three-level inspection at every stage
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