Module 18 2021

09/02/2021

What is Usability Engineering? What is Human Factors?

The Organisation for Professionals in Regulatory Affairs

Assessing Usability and Performance during development

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What is Usability Engineering? What is Human Factors? Usability Engineering is the – “ APPLICATION OF KNOWLEDGE ABOUT HUMAN BEHAVIOUR , ABILITIES , LIMITATIONS , AND OTHER CHARACTERISTICS TO THE DESIGN OF MEDICAL DEVICES ( INCLUDING SOFTWARE ), SYSTEMS AND TASKS TO ACHIEVE ADEQUATE USABILITY .”

IEC 62366-1:2015, S ECTION 3.17

 Usability Engineering is comparable to Human Factors Engineering in its process – most regulators combine both into one process.

 Usability engineering originated in the consumer industry.  It focuses on validating the process of user interaction.

USER INTERACTION

The Organisation for Professionals in Regulatory Affairs

Assessing Usability and Performance during development

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