Human Factors Usability Training Overview
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.
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 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. This process conforms to the new ISO 62366 standard and the new FDA Guidance document.
Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar
- User error versus use error
- Use related hazards and risk analysis
- User profiles
- Use scenarios
- Step by step human factors program development
Who Will Benefit from this Human Factors Usability Course
- Engineer management
- Quality assurance
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.