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Laboratory Testing

Innovative Quality Platform for Medical Device Lifecycle Excellence

As a premier testing service provider under All Bright Medical, Integrity Testing operates dual laboratories in Shanghai and Suzhou, delivering comprehensive quality solutions across the entire medical device lifecycle. Our comprehensive capabilities span material science (physical/polymer/chemical analysis, chemical characterization), device validation (electrical safety/EMC, environmental reliability, MRI safety), and human-centered evaluation (human factors engineering, software validation).

Operating under globally recognized ISO 17025, ISO 13485, and GMP frameworks, we enforce rigorous quality controls across personnel, equipment, methods, and environments. The LabVantage LIMS-powered traceability system ensures GAMP5-validated data integrity and compliance throughout sample lifecycle management—from receipt to disposal—accelerating regulatory approval for medical devices across with internationally accepted test reports.

  • 560
    +
    CNAS approval parameters
  • 250
    +
    CMA approval parameters
  • 100
    +
    Professional Personnel
  • 550
    +
    Professional Equipment
  • 7200
    +
    Area (㎡)
Non-active Testing Service
  • Chemistry
  • Material Characterization
  • Physics
  • Microbial
Drug Identification, Impurities, Content, Release Testing
Chemical Properties (Reducing Substances, Heavy Metals, Residue on Evaporation, UV Absorbance, pH, Turbidity, Color/Coloration)
Corrosion Evaluation (Galvanic Corrosion, Corrosion Susceptibility, Corrosion Resistance)
Sterilization Residues (Ethylene Oxide, 2-Chloroethanol)
Solvent Residues (Ethanol, Isopropanol, Acetone, Tetrahydrofuran)
Orthopedic Implant Cleanliness (Total Hydrocarbons (THC), Total Organic Carbon (TOC), Conductivity, Bioburden, Insoluble Particles, Endotoxin)
Chemical Characterization: Unknown Leachable Screening Analysis, Targeted Leachable Quantification
Packaging/Drug Compatibility Studies
Polymer Medical Device Degradation Studies (In Vivo/In Vitro)
Chemical Structure Analysis
Morphology Observation and Elemental Analysis
X-ray Phase Analysis
Material Hardness
Nickel-Titanium Alloy Phase Transformation Temperature
Metallography: Microstructure, Grain Size, Non-metallic Inclusions, etc.
Glass Transition Temperature
Melting/Crystallization Temperature and Enthalpy
Thermal Decomposition Temperature and Weight Loss Rate
Polymer Dilute Solution Viscosity
Polymer Average Molecular Weight, Molecular Weight Distribution and Content
Material Rheological Properties
Material Dynamic Mechanical Properties
Packaging System Performance & Stability: Real-Time/Accelerated Aging, Sterile Barrier System Integrity (Seal Strength, Dye Penetration, Gross Leak Detection, Seal Integrity, Microbial Barrier)
Physical Performance Testing
Vascular Stents, Stent Systems & Delivery Systems
Catheters and Catheter Accessories
Luer Connectors (e.g. Luer Lock Function, Leakage Resistance, Separation Force)
Stent Pulsatile Durability (Including Particulate Fatigue Testing)
Sterility, Bioburden, Endotoxin, Particulate Contamination
Microbial Limits, Particulate Matter
Sterilization Confirmation of Medical Devices (Moist Heat sterilization, Low Temperature Gas Peroxide Sterilization, Liquid Chemical Sterilization and Dry Heat Sterilization)
Validation of Cleaning, Disinfection and Sterilization of Reusable Devices
Validation of Disinfectant Efficacy
Antimicrobial Test
Cleaning and Sterilization of Clean Clothes
Active Testing Service
  • Electrical Safety
    General Standards
    Impedence of Earthing
    Dielectric Strength
    Defibrillation
    Specialized Standards
    Endoscope
    High Frequency
    In Vitro Diagnostics
  • EMC
    General Standards
    Radiated Emission
    Conducted Emission
    Radiation Immunity
    Radio Frequency Conduction
    In Vitro Diagnostics
  • Environment and Reliability
    Packaging and Transportation Test
    Environmental Adaptability Assessment
    Highly Accelerated Life Test (HALT)
    Salt Spray (Fog) Test
    Waterproof Test
  • MRI
    Active MRI Safety Evaluation
    Radiofrequency Heating
    Induced Voltage
    Rectification
    Failure
    Gradient Heating
    Vibration
    External Potential
    Static Magnetic Field Displacement Force
    Torque
    Composite Field Test
    Non-active MRI Safety Evaluation
    Artifact
    Displacement Force
    Torque
    Heating
  • Usability
    Usability Standards Compliance Testing
    Formative Usability Testing
    Summative Usability Testing
  • Software Evaluation
    Network Security Test
    Vulnerability Scan Detection
    Analysis of Network Security Capability
Technical Service
  • GMP Utility Validation
    Cleanroom Validation - Environmental Control and Process Assurance
    HVAC\Water System\Process Gas
    Design review, Installation, Operation and Performance Validation
    Develop Appropriate Validation Strategies Through Risk Assessment
    EMS Online Monitoring System
  • Cleaning Process Validation
    Systematic Verification from Surface Cleaning to Personnel Behavior
    Validation of Surface Cleaning Effectiveness and Cleaning Cycle for Objects
    Validation of Cleaning Effectiveness for Materials and Equipment Entering Cleanrooms
    Personnel Gowning Validation and Usage Cycle Validation for Cleanroom Garments
    Validation of Disinfection Cycle for Personnel Gloves
    Cleanroom Space Disinfection Validation
    Orthopedic Cleanliness Validation
  • New Laboratory
    CMA/CNAS Compliance System Development
    Establishment and Improvement of Quality System
    Mock Review
    Standard Analysis and Training
    Assist in New Test Methods, Equipment Maintenance Documents, etc.
    Skill Training
  • Software and Hardware Validation
    Lifecycle Compliance Validation
    Validation Documentation
    Complex and Precision Analytical Equipment and Systems
    Routine Analytical Equipment
    Disinfection and Sterilization Equipment
    Cleanroom Equipment
    Temperature Control Equipment
    Laboratory Information Management Systems
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No. 766, Nanxiang Road, Jiangling Street, Wujiang District, Suzhou City, Jiangsu Province
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contact@prosteri.com
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