Module 18 - Drug Device Combinations and Other Technologies

07/12/2023

DDCP Knowledge

Question – Where do people use rescue inhalers?

In summary: If you don’t know the answer – perform user research to find out! Then take the knowledge gained and check it out! Perform a human factors study in the right manner – remove bias! The result – verification of the use environment.

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Why is this important? If you don’t then test the design of the device in the right use environment, future data could be unrealistic and create negative bias. Regulators will see that you performed the process differently!

The Organisation for Professionals in Regulatory Affairs

Human Factors for drug device combination products

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What is Usability Engineering? What is Human Factors?

The Organisation for Professionals in Regulatory Affairs

Human Factors for drug device combination products

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