Medical Device Materials Testing Laboratory

Medical grade materials, devices/products, and implants must meet the highest quality standards. Whether your organization requires materials testing, chemical analysis, mechanical testing, or failure analysis, SGS MSi provides comprehensive testing and certified laboratory test reports to ensure the quality levels required by the medical industry.

Our experienced metallurgical engineers provide reports that start with a clear summary of our findings and conclusions; followed by a detailed review of our findings and possible suggestions to prevent issues in the future. The reports include the information necessary to show your material meets the required specifications.

SGS MSi’s technical staff is experienced in analyzing and testing titanium, stainless steel and other metals used for medical devices/products and implants. Our metallurgical and mechanical testing services will verify the materials used are consistent with technical specifications and performance characteristics. Additionally, SGS MSi engineers are experienced in testing laser etched, chemically-etched, and electrically-discharged machined (EDM) materials to ensure the etching/process will not affect material or product performance.

Available Testing Services for Medical Devices

    • Metallurgical Testing Services – Covers titanium, stainless steel and specialty metals used in medical implants and products. Such testing ensures the composition of your materials, heat treat process, and/or cleanliness meets product requirements and stringent regulatory and safety industry standards. Our test laboratory is A2LA and ISO 17025 accredited. We provide certified reports detailing traceable and repeatable documentation showing the testing performed and the data obtained.
    • Mechanical Testing – SGS MSi’s laboratories offer a full suite of mechanical testing to verify that your product meets tensile, hardness, and surface roughness requirements. We can certify results to standard or internal specifications.
    • Engineering Services - We offer confidential, unbiased evaluation of materials and products to help understand material failures and resolve any materials or product claims. Our knowledgeable engineers perform extensive testing and analysis to identify the issue and root cause of any problems experienced with your materials. Additional SGS MSi services include specifications review and reverse engineering.

Scanning Electron Microscopy (SEM)/Energy Dispersive Spectroscopy (EDS) – SEM/EDS analysis are used to obtain a high resolution, high depth of field images as well as an elemental composition for a bulk material, or a particular area of that material. SGS MSi has the capability to evaluate and document:

      • Fractography and failure analysis of ferrous and non-ferrous metal parts
      • Surface features analysis
      • Unknown materials identification
      • Alloy phase identification
      • Coating/Plating thickness

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