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Usability Studies
Usability testing is an important part of the Medical Device approval process. The FDA recommends that the prospective device is put through a non-clinical, realistic human factors test, also known as a Usability Test. This process should be done in addition to device design Validation, as it may not be possible to evaluate the performance of the device in use scenarios otherwise. The ultimate goal of Usability Testing is to ensure that the device performs safely, under realistic conditions when operated by the prospective user. This should be done with minimal training and dependence on labeling.

Biometrix provides the following services around usability testing:

  • Creation of usability tests
  • Recruitment of usability test participants
  • Execution of usability tests
  • Preparation of final reports
  • User manual testing and consulting