Human Factors/ Usability Studies following ISO62366, the FDA Guidance, and the new FDA Draft Guidance

Edwin Waldbusser Instructor:
Edwin Waldbusser 
Friday, August 2, 2024
10:00 AM PDT | 01:00 PM EDT
60 Minutes
Webinar ID: 502282

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Price Details
Live Webinar
$149 One Attendee
$299 Corporate Live
Recorded Webinar
$199 One Attendee
$399 Corporate Recorded
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Live + Recorded
$299 $348 Live + Recorded
Corporate (Live + Recorded)
$599 $698 Corporate
(Live + Recorded)

Live: One Dial-in One Attendee

Corporate Live: Any number of participants

Recorded: Access recorded version, only for one participant unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)

Corporate Recorded: Access recorded version, Any number of participants unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)

Overview:

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.

Why should you Attend: The FDA will only approve devices that 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 user 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 the use of specification templates, user interface evaluation templates, and usability validation control forms.

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
  • Validation

Who Will Benefit:
  • Engineer
  • Engineer Management
  • Quality Assurance
  • Regulatory


Speaker Profile
Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the US and internationally in the areas of design control, risk analysis and software validation for the past 8 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.


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