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Medical Devices Quality Control Management and Testing

Lucideon's medical device quality control testing, management and validation services are supported by state-of-the-art analytical equipment and testing facilities.

Our team of highly qualified and experienced technical staff will work with you to develop and deliver specialized testing and analytical solutions to add value to your product or project.

We specialize in a range of testing on both raw materials and final products, including:

Raw Materials

  • Chemical Analysis via ICP-OES, GC-MS, LC-MS, IC, etc.
  • Mechanical Analysis, e.g. tensile, hardness, toughness, etc.
  • Surface Imaging & Microstructural Analysis via microscopy, SEM, electron microprobe, surface science
  • Cleanability Evaluations

Final Products

  • Cleaning and Sterilization Validation
  • Static and Fatigue Testing
  • Coating Evaluations for Hydroxyapatite and Porous Metals
  • Particulate Analysis
  • Surface Imaging & Microstructural Analysis
  • 3D Strain Analysis
  • Residuals Analysis

All of the above can help to benchmark and/or characterize your materials and products to compare new designs with existing designs, accelerate product developments, support regulatory submissions, validate new coatings and processes, help comply with regulations (e.g. UDI), or troubleshoot challenges (e.g. surface staining).  Whether your goal is solving challenges that you’re currently faced with, or preventing those of the future, our wide range of analytical tools and experience can help support you in your pursuit of quality, and quality control. 

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Resources

  • White Paper

    Cleaning and Sterilization Validation of Reusable Medical Devices
    pdf (333 KB)

  • White Paper

    Medical Devices - Cleanliness Validation
    pdf (812 KB)

  • Data Sheet

    Cleanliness Validation
    pdf (528 KB)

  • Webinar Recording

    How Clean is Your Device?
    The Use of Surface Chemical Analysis for the Validation of Device Cleaning Processes

    Watch the recording here