What is Human Factors Engineering?

About Sterling Medical Devices
At Sterling we incorporate usability engineering into clients’ existing development processes.

Human Factors Engineering is an approach to evaluating and improving the design of devices that fit the human body and its cognitive abilities. Specifically for Medical Devices, engineers will assist in design optimization through human factors analysis, testing and validation through a usability engineering process. This allows for the determination of potential sources of use errors, with the goal of improving the safety and efficacy of medical devices to fit the needs of practitioners and patients.

How Can We Help?

We can assist customers with incorporating usability engineering into their existing development process to provide safety to the patient and/or user with respect to usability.

Sterling can assist you in your Human Factors Engineering by:

  • 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  • Meeting the ISO 62366 Standard and FDA Draft Guidance for Applying Human Factors

Sterling brings its medical device design, development, and testing capabilities to human factors engineering. Our experienced engineers will work with you to ensure your medical device includes all aspects of human factors usability.