- TypeWebinar
- Location Online Event
- Date 19-01-2024
Education/Teaching/Training/Development
Administration/Management
Accounting/Financial/Banking/Insurance
Fresher/Trainee/Professionals
OTHERS
OVERVIEW
Human Factors/Usability is the analysis of how people interact with medical devices. Human factors usability validation is a process of evaluating a product's usability by testing it with representative users in a simulated or real-world environment. The objective of human factors usability validation is to identify and address potential usability issues and ensure that the product is safe, effective, and easy to use.
The process involves planning and preparation, selecting appropriate participants and testing environment, conducting user testing and data collection, analysis and interpretation of data, and reporting and documentation of results. A successful human factors usability validation can improve the product's usability, user satisfaction, and overall market acceptance.
WHY SHOULD YOU ATTEND?
This webinar will guide attendees through the process of conducting human factors studies from start to finish. The speaker, Jose Mora, will explain how to integrate these studies with device risk analysis and will cover the process of validating the effectiveness of the studies.
Following the implementation of the results of a Human Factors/Usability study, he will explain how it is necessary to conduct a validation to ensure the device's safety and effectiveness during use. He will explain why several validation participants from each "distinct user population" are required by the FDA. He will also explain how to choose the tests to be conducted and the studies that need to be completed before the actual validation test. Furthermore, Jose will be describing how to perform the critical post-test participant inquiry, which is important for the success of the validation.
Handouts are usability validation tracking forms, protocol forms, and test results report forms.
AREAS COVERED
WHO WILL BENEFIT?
This webinar will provide valuable insights to - Engineers, Managers, Supervisors, Directors, and Vice-Presidents in the areas of: