Module 14 2022
24/03/2022
What is the Human Factors and Usability Engineering process?
The Organisation for Professionals in Regulatory Affairs
Human Factors and usability testing during development
15
What is the Human Factors and Usability Engineering process?
The human factors engineering process is part of the development of the drug device combination product. It follows a traditional path – Research, Design, Develop, Verify and Validate.
Research
Design
Develop
Verify
Validate
The key elements are:
User research. Risk Management of use-based risks.
Abnormal Use
Typical Use Hazardous Use
Mis-Use
Development and the design of User Interfaces. Verification and Validation of the drug device combination product with intended users, in the intended use environments.
The Organisation for Professionals in Regulatory Affairs
Human Factors and usability testing during development
16
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