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Medical Device Testing

Medical device testing is a critical process to evaluate product safety, quality, and suitability prior to clinical or healthcare use. ALS provides laboratory testing services to support chemical, elemental, and microbiological assessment of medical devices, ensuring compliance with applicable international standards and regulatory requirements.

Scope of Services

  • Chemical Analysis of Medical Device Materials and ProductsEvaluation of material composition and relevant chemical parameters associated with product safety and potential extractables or residues.
  • Elemental and Heavy Metals AnalysisDetermination of elements such as Aluminium, Arsenic, Cadmium, Chromium, Lead, Mercury, Nickel, Selenium, Silver, Zinc, and Total Heavy Metals to assess compliance with safety limits and risk-based requirements.
  • Microbiological and Biological Testing, including:
    • Specific Microorganism Testing
    • Non-Specific Microorganism Testing
    • Sterility Testing
    • Challenge Testing (Preservative Effectiveness Test, where applicable)
    • Bioburden Testing
    • Biological Indicators Resistance Performance Testing
    • Bacterial Endotoxin Testing (BET)

      • All analyses are performed in accordance with recognised standards such as the United States Pharmacopeia (USP) and other applicable international microbiological and sterility testing guidelines. This ensures accurate, reliable, and compliance-ready results suitable for safety assessment and regulatory submission of medical devices.

 
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