Human Factors/usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the medical device risk analysis and design process, and validating the effectiveness of the studies will be explained. The various types and methods of human factors/usability analysis will be explained. This process conforms to the new ISO 62366 standard and the new FDA Guidance document.

WHY SHOULD YOU ATTEND

The FDA will only approve devices which are so designed that it is practically impossible for people to accidentally harm themselves even if they use the device improperly. The FDA has replaced the term “user error” with “use error”. This means that use error is considered by the FDA to be device nonconformity because human factors/ usability should be considered in the design process. The burden is on the device designer to follow usability studies, perform medical device risk analysis and create an “idiot proof” product.

Handouts are use specification template, user interface evaluation template, and usability validation control form

AREAS COVERED

• Difference between user error and use error 

• Use related hazards and risk analysis

• User profiles

• Use scenarios

• Step by step human factors program development

• validation

LEARNING OBJECTIVES

Learn about use related hazards and risk analysis in medical devices and how to create a device that complies with the FDA guidance. Know how to assess human factors/usability in the design process and maintain compliance with ISO 62366.

WHO WILL BENEFIT

• Engineer

• Engineer management

• Quality assurance

• regulatory

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