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SGS supports its partners in the medical device industry with a broad range of services.

We perform hygienic qualification of production facilities, microbiological tests on products before and after sterilization, and screen for possible residual contaminants from the sterilization process (endotoxins, ethylene oxide). We can also conduct studies for migration of substances from packaging material (leachables).

Our Medical Device Testing Services include:

  • Determination of bioburden before sterilization
  • Sterility testing according to USP and EP of products and biological indicators
  • Method development and validation
  • Package expiration dating studies
  • Endotoxin testing
    • Gel clot, kinetic, and chromogenic
    • Residual ethylene oxide testing according to EN ISO 10993-7
    • Environmental monitoring of production zones
      • Viable and nonviable particulate analysis
      • RODAC and swab analysis of surfaces
      • Cytotoxicity bioassay
      • Polymer identification
        • FTIR, TGA, DSC
        • Container Closure Permeation
          • Dye and microbial ingress studies
          • Test for leachable substances according to EN ISO 10993-173

          Contact SGS today to learn how we can help with quality control testing for your medical devices.