Preclinical Testing for your medical device

  • Access a comprehensive network of trusted partners in device testing
  • Validation & verification to international harmonised standards
  • Demonstrate compliance with relevant GSPRs under EU MDR & IVDR

  • Biocompatibility Testing

    Assess the biocompatibility of your medical device's materials & processes with a holistic, risk-based approach to ISO 10993 standards.

    • Formulate a Biological Evaluation Plan to outline required testing for your device
    • Evaluate the biocompatibility of your medical device & its component materials
    • Determine the interaction of your device with the body's immune system with sensitisation testing
    • Identify irritation reactions in the skin, mucosal or ocular tissues that interact with your device
    • Select & perform relevant additional biocompatibility tests from the 24 possible categories under ISO 10993

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  • Usability Testing

    Ensure the safety, efficacy & usability of your medical device in real-world conditions.

    • Test your device in the environments & situations it will commonly be used, in line with ISO 62366
    • Comprehensive analysis of usability & user experience
    • Accurate & actionable feedback during your device's development

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  • Electrical Equipment Testing

    Be confident your medical device meets essential electronic performance & safety requirements for patients.

    • Conduct advanced EMC testing in accordance with IEC 60601 standards
    • Verify that your device does not cause harmful interference & functions as originally intended
    • Test the ability of your device to withstand interference from other electronic equipment & its surrounding environment
    • Minimise the risks of electrical hazards to patients & users of your device
    • Meet IEC 60601 regulatory obligations to gain market access in a wide variety of countries

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  • Packaging Standards Testing

    Be certain that your device meets the ISO 11607 harmonised standards for sterile packaging systems.

    • Use accelerated aging tests to simulate & evaluate the shelf life of your device
    • Packaging integrity & strength tests assure your customers that your packaging is reliable & will withstand the rigours of clinical use
    • Clinical contamination testing demonstrates the sterility of your device packaging

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  • Other testing services

    We also provide other pre-clinical tests critical to achieving market compliance.

    • Mechanical & functional testing
    • MRI compatibility
    • Transit & distribution testing
    • Particle & powder characterisation
    • For any other pre-clinical tests, please contact our team to discuss further

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  • 77% Return Customers
  • 100% Notified Body Approval

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