Human Factors/ Usability Studies following ISO62366 and the new FDA Guidance

OVERVIEW

Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the medical device 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 use related hazards and risk 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 designed so 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 a device nonconformity because human factors should be considered in the design process. The burden is on the device designer to create an “idiot proof” product.
Handouts are use specification template, user interface evaluation template, and usability validation control form.

AREAS COVERED

• 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 the need and basic concept of medical device risk analysis and how it impacts the medical device design process. Also learn about the FDA regulations that govern the device design and usability studies.

WHO WILL BENEFIT

• Engineer
• Engineer management
• Quality assurance
• Regulatory

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