Fast-Track Medical Implant Manufacturing

— Accelerating Market Launch

· OEM CNC Manufacturing

· ISO 13485:2016 Certified

· 35+ CNC Machines & Post-Finishing

· 60+ Materials Available

· From Prototypes to Volume Production

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Our comprehensive inspection and quality control system ensures full compliance with ISO 13485, delivering reliable, traceable quality for every orthopedic component.

Inspection & Quality Control

Digital Calipers for Medical Implant & Component Dimensional Inspection - ISO 13485 Compliant

Calipers

Linear Dimension Measurement

2D Video Projector for Medical Component Dimensional Inspection & Quality Control

2D Projector

CMM (Coordinate Measuring Machine) for Medical Implant Dimensional Inspection

CMM

3D Geometric Measurement

Micrometer

Micro-Dimension Measurement

Hardness Tester for Medical Implant Material Performance Testing

Hardness Tester

Hardness Testing

Height Gauge for Medical Component Dimensional Inspection & Quality Control

Height Gauge

Height & Step Measurement

Color Difference Meter for Medical Component Surface Quality Inspection

Color Difference Meter

Color Uniformity Check

2D Profile Inspection

Metal Composition Analyzer for Medical Implant Material Verification & Traceability

Metal Composition Analyzer

Material Composition Analysis

Digital Micrometer for Medical Implant & Component Dimensional Measurement - ISO 13485 Certified

Technical Specifications

1. Dimensional & Geometric Inspection

Process Introduction

Precise measurement of dimensional tolerances, geometric dimensions and positional accuracy to ensure medical devices parts meet strict clinical and engineering requirements.

Included Equipment

· 2D Projector

· CMM (Coordinate Measuring Machine)

· Micrometer

· Height Gauge

· Calipers

Technical Specifications

Machine Type
Max. Workpiece Size (mm)
Spindle Speed
Control System 
2D Projector
±0.001 mm
2D Profile & Dimension
0-300 mm
3D Geometric Tolerance
CMM
±0.002 mm
0–500 mm
Micro-Dimension
Micrometer
±0.001 mm
0–25 mm / 25–50 mm
Height & Step
Height Gauge
±0.002 mm
0–300 mm
Linear Dimension
Calipers
±0.01 mm
0–150 mm / 0–300 mm

2. Material & Composition Analysis

Process Introduction

Accurate identification and verification of medical-grade material composition to ensure biocompatibility and mechanical performance of medical devices components, complying with ISO 13485 requirements.

Included Equipment

· Metal Composition Analyzer

Technical Specifications

Parameter
Specification
Mg–U (periodic table elements)
±0.01%
Detection Range
10–30 seconds per sample
Accuracy
Analysis Time

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 medical devices, like orthopedic implants and instruments.

Included Equipment

· Color Difference Meter

· Surface Profilometer (supplementary for post-finishing validation)

Technical Specifications

Inspection Item
0.1–100 μm
Ra 0.025–10 μm
Surface Roughness (Ra)
Coating Thickness Gauge
Surface Profilometer
Coating Thickness
Equipment
Specification
Color Uniformity
Color Difference Meter
ΔE ≤ 1.0
Coating Adhesion
Scratch Tester
≥30 MPa

4. Hardness & Mechanical Property Testing

Process Introduction

Measurement of material hardness and mechanical properties to ensure the durability and reliability of medical devices parts under clinical load conditions.

Included Equipment

· Hardness Tester

Technical Specifications

Test Type
Hardness Range
HRC 20–70
HV 100–1000
Rockwell Hardness
HB 100–500
Vickers Hardness
Brinell Hardness
CMM (Coordinate Measuring Machine) Inspection Process for Medical Implant Components - ISO 13485 Com

Fast-Track Medical Precision Inspection

Quality is Assured

· ISO 13485 certified QMS for medical device inspection

· High-precision measurement & FAI reports, tolerance control down to ±0.02 mm

· Full traceability of inspection data from raw material to finished product

· Professional inspection team with medical device expertise

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Ready to start your project? Send us your drawings, and we’ll reply with a quote in 1-24 hours.

Tel: +86 18718750572

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Email: enquiry@honlike.com.cn

WhatsApp: +86 18718750572

101-103, Building 8, Bay Area Intelligence Valley, West District, Zhongshan, 528411, GuangDong, China

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