validation and performance.

Access our in-house test equipment and specialised team to manage all product validation testing including Biocompatibility, Magnetic Resonance Testing, Cleaning, Packaging & Sterilisation. Our state of the art NATA certified equipment will test all relevant ASTM/ISO requirements for your medical device.

Regulatory authorities such as the TGA and FDA require comprehensive performance data to approve medical device applications. Actis Medical will leverage extensive experience in medical device performance testing to ensure your application meets all regulatory requirements.

Our experience includes;

  • Fatigue, wear and subsidence testing of implants
    (Hip , Knee, Spine, Trauma)
  • Tensile, compression & torque testing
    (Orthopaedic plates, screws , sports medicine)
  • Biocompatibility tests (ISO 10993)
  • Cleaning and Residual testing
  • Accelerated Ageing
  • Packaging Integrity Testing
  • Distribution Simulation Testing
  • Sterilisation (Gamma Irradiation and Ethylene Oxide)
  • Magnetic Resonance Imaging (MRI)