Human Factors/ Usability Studies following ISO62366 , the FDA Guidance and the new FDA Draft Guidance

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 This discussion conforms to the ISO 62366 standard, the FDA Guidance, and the new FDA Draft Guidance document.

The impact of the new draft guidance on the existing FDA requirements for a HF program will be discussed.

Areas Covered in the Session:-

• User error versus use error
• Use related hazards and risk analysis
• User profiles
• Use scenarios
• Step by step human factors program development
• Human Factors validation
• Impact of new draft guidance on the HF program

Why Should You Attend:-

The FDA will only approve devices which are designed so that it is difficult for people to accidentally harm themselves or others 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.

Who Should Attend:-

• Engineer
• Engineer management
• Quality assurance
• Regulatory.