Human Factors Engineering

Human Factors Engineering

Human Factors Engineering, or as some call it ergonomics, is the process of evaluating and changing the design of devices to better fit the human body and its cognitive abilities. This is accomplished by using the scientific method to view human behaviors and adapt devices to be better used by its users. When it comes to medical devices, this occurs during the usability engineering process, during which engineers use human factors analysis, testing, and validation to adapt the device’s design to ensure optimization.

Specifically for Medical Devices, engineers will assist in design optimization through human factors analysis, testing and validation through a usability engineering process. Sterling uses human factor engineering through the design process to ensure that a medical device is safe and efficient for any users.

Ways Sterling can assist you in your Human Factors Engineering

• Identifying and tracing requirements related to usability
• Identifying hazards and hazardous situations related to usability
• Analyzing residual risk associated with usability
• Assisting in implementing the user interface using usability engineering methods
• Assisting in usability validation
• Assisting in the preparation of a usability engineering file
• Meeting the ISO 62366 Standard and FDA Draft Guidance for Applying Human Factors