Module 18 - Drug Device Combinations and Other Technologies

07/12/2023

Why is Human Factors and Usability Engineering important?

https://www.youtube.com/watch?v=zSSoYmQS6Ng

The Organisation for Professionals in Regulatory Affairs

Human Factors for drug device combination products

17

Why is Human Factors and Usability Engineering important?

 To ensure the intended users can use the DDCP.

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

 To ensure that the intended user receives the clinical performance they expect when using the DDCP.

 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 DDCP 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 DDCP.

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

The Organisation for Professionals in Regulatory Affairs

Human Factors for drug device combination products

18

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