Our comprehensive inspection and quality control system ensures full compliance with ISO 13485, delivering reliable, traceable quality for every orthopedic component.
Inspection & Quality Control
Calipers
Linear Dimension Measurement
2D Projector
2D Profile Inspection
CMM
3D Geometric Measurement
Micrometer
Micro-Dimension Measurement
Metal Composition Analyzer
Material Composition Analysis
Hardness Tester
Hardness Testing
Height Gauge
Height & Step Measurement
Color Difference Meter
Color Uniformity Check
Technical Specifications
1. Dimensional & Geometric Inspection
Process Introduction
Precise measurement of dimensional tolerances, geometric dimensions and positional accuracy to ensure orthopedic implants and instruments meet strict clinical and engineering requirements.
Included Equipment
· 2D Projector
· CMM (Coordinate Measuring Machine)
· Micrometer
· Height Gauge
· Calipers
Technical Specifications
2. Material & Composition Analysis
Process Introduction
Accurate identification and verification of medical-grade material composition to ensure biocompatibility and mechanical performance of orthopedic components, complying with ISO 13485 requirements.
Included Equipment
· Metal Composition Analyzer
Technical Specifications
3. Surface & Coating Quality Inspection
Process Introduction
Comprehensive evaluation of surface roughness, coating thickness, color uniformity and adhesion to meet the surface quality requirements of orthopedic implants and instruments.
Included Equipment
· Color Difference Meter
· Surface Profilometer (supplementary for post-finishing validation)
Technical Specifications
4. Hardness & Mechanical Property Testing
Process Introduction
Measurement of material hardness and mechanical properties to ensure the durability and reliability of orthopedic implants and instruments under clinical load conditions.
Included Equipment
· Hardness Tester
Technical Specifications
Orthopedic Precision Inspection
Core Inspection Advantages
· ISO 13485 certified quality management system for orthopedic medical device inspection
· High-precision measurement with tolerance control down to ±0.001 mm
· Full traceability of inspection data from raw material to finished product
· Professional inspection team with deep expertise in orthopedic device standards·
Get A Quote
If you have requirements for precision machining, prototyping or small batch production of orthopedic implants and instruments, please feel free to send us your drawings and specifications.We will provide you with a professional quotation and solution within 24 hours.