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Human Factors

Human factors and usability are a topic of increased focus by the FDA. Providing objective evidence of performed usability studies can prove difficult for a small company with limited resources or a large company stretched too thin. Often, the team performed the simulated or actual use testing but the documentation of the testing did not satisfy the FDA requirements.

Tietronix has expertise that can relieve the burden and provide the additional resources needed to document or perform usability testing.