Module 18 2021

09/02/2021

What is the Human Factors and Usability Engineering process? What documentation should be included in a Human Factors and Usability Engineering process?  Use Specification – where the intended users, use environments and use scenarios are defined.  Task Analysis – where the intended tasks and use scenarios are determined.  Usability/Human Factors Risk Assessment – where task-based risks are evaluated and use- based risk determined.  User Interfaces / Validation Test Plan – where the user interfaces are defined and their routes for verification and validation are determined.  Formative Usability/Human Factors Studies – where design concepts, user interfaces, software, hardware and the final design of the device are tested with intended users to verify the design.  Summative Usability/Human Factors Test – where production-level devices are tested with intended users, in the intended use environment, under typical use conditions to validate the device design meets the users needs.  Usability/Human Factors Engineering File – where all the usability and human factors effort is contained.

The Organisation for Professionals in Regulatory Affairs

Assessing Usability and Performance during development

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When should the Human Factors and Usability Engineering process be applied?

The Organisation for Professionals in Regulatory Affairs

Assessing Usability and Performance during development

18

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