Module 18 - Drug Device Combinations and Other Technologies

07/12/2023

What is the Human Factors and Usability Engineering process?

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Human Factors for drug device combination products

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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.

Hazardous Use

Abnormal Use

Typical 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.

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Human Factors for drug device combination products

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