Medical Device Testing Solutions
Precision Testing for Medical Devices
Our precision testing solutions for medical devices cover dimensional, contour, hardness and mechanical performance inspection. With high-precision measurement technology, we meet ISO medical compliance and quality control standards. Suitable for sampling inspection, R&D verification and mass production testing, helping medical devices achieve safe, compliant and efficient market launch.
Medical Compliance Precision Testing
With standardized compliance and precision testing technologies, we fully ensure the accuracy, safety and clinical reliability of medical devices.
Standard & Compliant
It complies with ISO standards, medical access rules and medical device regulations, featuring standardized testing procedures to meet market certification requirements.
Medical Customized Solution
Custom testing solutions for medical consumables, precision components, implants and complete medical instruments.
Safety & Reliability Focused
Centered on medical safety indicators to reduce risks and ensure the reliability of products in clinical application.
Success Stories
Measurement Solution Case Study
Focusing on measurement scenarios, we present solutions and application values through practical cases.
Medical Precision Measurement Testing Case
Accuracy Detection, Performance Verification, Compliance Testing
Test Background
This equipment is used for precision measurement of the size of orthopedic implants and needs to pass NMPA registration. The core pain points are the lack of precision traceability and benchmark drift after long-term use, which makes it difficult to meet the ISO 10360-7 standard and may lead to deviations in the size matching of implants.
Solution
CMA-certified standard gauge blocks (error ≤ 0.0001mm) are used to calibrate the X, Y, and Z axes, and a laser interferometer is used to detect and compensate for positioning errors to ensure a measurement accuracy of ±0.001mm; a 72-hour continuous test is carried out to control data drift ≤ 0.0005mm, the constant temperature system is optimized to adapt to the clinical laboratory environment, and a traceability calibration mechanism is established every 6 months.
Implementation Effect
The equipment meets relevant standards and registration requirements, the precision stability is improved by 45%, the traceability rate of measurement data is 100%, and the qualified rate of implant size measurement is increased from 95% to 99.9%, which is applied in many enterprises and Grade A tertiary hospitals.
Metallographic Testing Solutions for Medical Implants
Compliant Quality Control, Ensuring Clinical Safety
Titanium Alloy Metallographic Test
A medical device manufacturer produces orthopedic, vascular and dental implants. Due to non-standard and inaccurate testing processes, it adopted metallographic equipment for quality control in accordance with ISO 13485. Standard sample preparation eliminates manual defects and ensures biocompatibility. Samples are processed with precision cutters, cold mounting machines and automatic grinders, controlling surface roughness below Ra 0.2μm. Tested by metallographic microscopes and SEM, three batches of unqualified samples were optimized to meet standards, improving clinical success rates.
Stent Welding Metallographic Detection
Metallographic equipment is used to inspect the welding quality of vascular stents to prevent clinical fractures. Standard sample preparation displays welding seams for accurate defect detection. After optimizing process parameters, the welding qualification rate increased from 89% to 97.5%.
Pure Titanium Implant Metallographic Detection
A full-process testing system based on metallographic equipment ensures quality and compliance. Raw materials are inspected under metallographic microscopes to avoid segregation and excessive inclusions, controlling quality from the source.