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

Webinar Takeaway

  • User error versus use error
  • Use related hazards and risk analysis
  • User profiles
  • Use scenarios
  • Step by step human factors program development
  • validation

Who Will Benefit from this Human Factors Usability Course

  • Engineer
  • Engineer management
  • Quality assurance
  • Regulatory

Choose a Purchase Option


$265

Live Webinar - Single Participant

You get one log-in for the live 60-minute webinar for one participant, presentation materials and the opportunity to ask questions by phone and email

$499

Live Group Up to 5 Participants + 12 month access

You get 5 log-in for the live 60-minute webinar for all the participant, presentation materials and the opportunity to ask questions by phone and email. 12 month Recorded Access is Included

$380

Recorded Access - 12 month Access

You'll have 12 month multiple user access to log-in for an archived recording of the entire 60-minute webinar, including the Q&A period . You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately 48 hours after the session

FDA Faculty Edwin Waldbusser

Edwin Waldbusser

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.