How to Conduct a Human Factors Usability Validation

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?

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 be explaining why a number of 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 prior to 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 form, protocol form, and test results report form.

AREAS COVERED

• Usability Engineering
• Safety
• Risk Management and Usability Engineering
• Use Specification
• Intended Users
• Anticipated User Tasks
• Intended Use Environment
• Human Factors Validation Testing

WHO WILL BENEFIT?

This webinar will provide valuable insights to - Engineers, Managers, Supervisors, Directors, and Vice-Presidents in the areas of:

• Design Assurance
• Document Control
• Manufacturing Engineers
• Operations
• Quality Assurance
• R&D

Others Details

This webinar will guide attendees through the process of conducting human factors studies from start to finish.