Human Factors and Usability Studies following ISO62366 and the new FDA Guid

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This discussion conforms to the ISO 62366 standard, the FDA Guidance, and the new FDA Draft Guidance document.

The impact of the new draft guidance on the existing FDA requirements for an HF program will be discussed.

• 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• Impact of new draft guidance on the HF program

• Engineer
• Engineer management
• Quality assurance
• Regulatory

medical device design control, software validation, artificial intelligence, and risk management consultant (FDA and EU MDR)

Mount Arlington, New Jersey, United States

Edwin Waldbusser retired from industry after 30 years in management of development of medical device products and development of company Quality Systems. He was involved in the development of products such as IVD devices, kidney dialysis systems and inhalation devices. His QS experience includes, design control, risk analysis, CAPA, software validation, supplier qualification/ control and manufacturing/non-conforming product programs. He now consults in the area of quality systems for medical devices with emphasis on design control, software validation, risk analysis and human factors analysis.

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