Module 18 2021

09/02/2021

Why is Human Factors and Usability Engineering important?  To ensure the intended users can use the product.

 To ensure that the intended users are safe when using the product.

 To ensure that the intended user receives the clinical performance they expect when using the device.  To ensure the intended user has everything required to be compliant to the medical regime the prescriber needs.

 To ensure that the user has the device when they need to use it.

 To ensure that the user can manage a medical regime, especially if they are a patient.

 To ensure there is a clinical benefit to the patient in using the device.

 To ensure that the intended user has a positive user experience.

The Organisation for Professionals in Regulatory Affairs

Assessing Usability and Performance during development

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What are the current Human Factors and Usability Engineering regulations?

The Organisation for Professionals in Regulatory Affairs

Assessing Usability and Performance during development

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