Human Factors Engineering - Medical Device

HFE is a scientific discipline concerned with the understanding of interactions among human and other elements of a system
it is Also called:
•Usability engineering
•Customer-centric design
•User-centered design
- A series of FDA standards and guidelines intended to ensure:
-“Each manufacturer shall establish and maintain procedures to ensure that the design requirement related to a device are appropriate and address the intended use of the device, including the needs of the users and patients.” (QSR paragraphs c, f, and g of Section 820.30)
-Ability to use a device safely and effectively is a primary “user need”
-Includes hardware, software and labeling