Human Factors/ Usability Studies following ISO 62366 and the new FDA Guidance

Posted By : User Ref No: WURUR68950 0
  • Image
  • TypeWebinar
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  • Location Littleton, Colorado, United States
  • Price
  • Date 27-10-2020
Webinar Title
Human Factors/ Usability Studies following ISO 62366 and the new FDA Guidance
Event Type
Webinar
Webinar Date
27-10-2020
Last Date for Applying
26-10-2020
Location
Littleton, Colorado, United States
Organization Name / Organize By
Global Wizdom
Organizing/Related Departments
Global Wizdom
Organization Type
Training/Development
WebinarCategory
Both (Technical & Non Technical)
WebinarLevel
All (State/Province/Region, National & International)
Related Industries

Education/Teaching/Training/Development

Manufacturing

Location
Littleton, Colorado, United States

Overview:
Human Factors/ Usability is an 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 are used specification template, user interface evaluation template, and usability validation control form.

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: Edwin Waldbusser
Edwin Waldbusser is a consultant retired from industry after 20 years in management of the 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 9 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.

Tags: design process, device risk analysis, Edwin Waldbusser, Engineer management, FDA Compliance, FDA Regulations, Human Factors, human factors program development, ISO 62366, methods of human factors analysis, New FDA Guidance, new FDA Guidance document, Risk analysis, Use related hazards and risk analysis, Use scenarios, User error versus use error, Validation

Others Details

Global Wizdom Contact :1-720-414-3543 [email protected] https://globalwizdom.com

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Phone
Website
Address/Venue
  Live - Webianrs Global Wizdom Contact :1-720-414-3543 [email protected] https://globalwizdom.com 
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