Human Factors Usability testing is a key component of the pre-clinical development of Medical Devices (including Digital Devices) and in vitro Diagnostics. Click to read more

Regulators will expect to see a Device Usability section in the risk section of the device Technical File. Ideally this should be performed as described in ISO 62366:2015

Testing should be undertaken by representative users, in a realistic environment but not on patients

With initial funding from Europe, MD-TEC has a purpose built, hi-fidelity simulation suite dedicated to device (including digital) and IVD usability testing

Watch a short video of what we do

Click here for a presentation about the challenges of getting medical devices in to healthcare

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