medical-device-testing

Performance Testing for medical devices

THAY Medical specialise in testing medical devices for performance and safety. Although our primary focus is on human factors and usability testing, we have the expertise to test all types of medical devices for performance and safety. This has come about due to the application of a human factors and usability engineering process. We find that it is not sufficient to just evaluate the user with a medical device, but also, increasingly it is important to check that a device has been produced to its specification beforehand. This is critical to have since if we evaluate the usability of a device that has not been produced to its specification, the data may be irrelevant. Human Factors and Usability Engineering regulations now require production-level product to be evaluated as part of summative (validation-level) testing. To assist with compliance, we are able to perform the following tests on medical devices:

  • Visual Inspection
  • Dimensional Inspection
  • Functional Inspection
  • Sound Pressure Level Testing
  • Flow Rate Testing
  • Occlusion Testing
  • Transport Testing

  • Drop Impact Testing
  • Free-flow Testing
  • Time to Bolus Dose Testing
  • Dose Accuracy Testing
  • Fatigue (Life-cycle) Testing
  • Biocompatibility Testing
  • Keypad / Button Testing

THAY Medical are able to write Test Protocols, perform the testing, analyse data, check for compliance and write Test Reports – to either internal templates or customer driven templates and test methods (other than those specified in reference standards). We focus on quick turnarounds and producing quality data. We believe the detail is very important and that the data produced from testing has to be repeatable, consistent and true as well as compliant. We operate to ASTM, ISO, IEC, JS, BS and DIN standards as well as to our own ISO 13485 Quality Management System.

If you have a medical device that requires verification or validation level performance testing, please contact us. We would love to help you evaluate your device.

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Infusion Devices

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Injection Devices

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Medical Devices