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SGS S.A.

  • 1 place des Alpes
  • P.O. Box 2152
  • 1211   Geneva 1
  • Switzerland
  • t   +41 22 739 91 11
  • f   +41 22 739 98 86
  • e   Email Us

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Medical Device QC Testing

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.

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          Lab ServicesLaboratory Services by SGSA comprehensive look at SGS’s global lab services (PDF 1,4MB) ...
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          Contact

          SGS S.A.

          • 1 place des Alpes
          • P.O. Box 2152
          • 1211   Geneva 1
          • Switzerland
          • t   +41 22 739 91 11
          • f   +41 22 739 98 86
          • e   Email Us

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          • JUN
            13

            Global Offshore Wind - Renewable UK 2012
            On June 13-14, 2012, SGS will be attending the 11th RenewableUK Global Offshore Wind 2012 Conference and Exhibition in London, UK. At stand 545, SGS’s team of experts will demonstrate a wide portfolio of renewable energy services for the entire project life cycle including, but not limited to, commissioning, in-service and end of warranty inspections, quality, health, safety and environmental (QHSE) management, risk management, non-destructive testing (NDT) as well as wind turbine blade testing.

          • JUN
            14

            SGS Webinar – New EU Toy Directive: Are You Up-To-Date?
            The objective of this 1-hour complimentary webinar is to give you an overview of the major changes of the new EU Toy Directive 2009/48/EC. We will provide a step-by-step implementation program to help you ensure compliance with all the new requirements.
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