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Human Factor and Usability Engineering

Human Factors Engineering (HFE) is a well-established discipline focused on optimizing interactions between people and products. Usability is a measure of the effectiveness, efficiency, and satisfaction with which specified users achieve specified goals in particular environments, within the scope of the intended use of the medical device. Many of these factors can influence safety to varying extents.

VTC helps customers meet the following needs:

• Develop an Human Factors Engineering program that satisfies current regulations and standards
• Develop user interface requirements as a foundation for design and verification.
• Conduct formative and summative (i.e., validation) usability tests.
• Produce a complete HFE design history file.
• Produce an HFE report for submission (as needed) to regulators.
• Produce the test report, according to Standard IEC 60601-1-6 and IEC 62366-1