2024 - How to Conduct a Human Factors Usability Validation

Overview
This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for compliant human factors/usability validation. HF/U validation is very different from device validation. For example, success criteria are qualitative rather than quantitative as is in device validation. Claiming success because eg. 95% of test participants did not commit a user error is not valid. Nor is 100% positive test results sufficient.
Why Should You Attend
Following the implementation of the results of a Human Factors/Usability study, a validation of the safety and effectiveness of the use of the device must be conducted. We will explain why the FDA required a number of validation participants from each "distinct user population". We will explain how to choose the tests to be conducted and the studies that must be completed prior to the actual validation test. The post-test participant inquiry is critical to validation success. we will describe how to do this. Handouts are usability validation tracking form, protocol form, and test results report form.
Webinar Takeaway
Required number of participants
Qualitative success criteria
Choice of tasks to validate
Post-test participant inquiry. Forms: Usability Validation Tracking Matrix
Validation Protocol
Validation Test Results Report will be given as Handouts
Who Will Benefit
Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
HR Compliance
Quality Management
Risk Management
Design Engineering