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Human Factors/ Usability Studies following ISO 62366 and the new FDA Guidance
Presented By Global Wizdom
Tuesday, October 27th at 1:00pm EST
Online sale ends: 10/27/20 at 12:30pm EST
Live -Webinar
Kellogg Center 26 West Dry Creek Circle, Suite 600
Littleton, CO 80120
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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.
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.

Global Wizdom
Contact :1-720-414-3543

Presented By

1:00pm to 2:45pm
Doors open at 12:30pm

General Admission: $159.00


Live -Webinar<br> Kellogg Center 26 West Dry Creek Circle, Suite 600<br> Littleton, 80120





Wednesday, October 21st

Past Event