How to Conduct a Human Factors/ Usability Validation

This webinar will explain the procedure described in ISO 62366, the FDA Guidance, and the new draft Guidance for a compliant human factors/ usability validation.

HF/U validation is very different from device validation. For example, success criteria is qualitative rather than quantatative, 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 Human Factors/ Usability preliminary study, a validation of the safety and effectiveness of the use of the device must be conducted if critical tasks are identified. The process of identifying critical tasks will be explained. We will explain the FDA required 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. We will explain the required number of participants from each "distinct user population".handouts areusability validation tracking form,protocol form, and test results report form

Areas Covered in the Session:

• Required Number of Participants
• Qualitative Success Criteria
• Choice of Tasks to Validate
• Post Test Participant Inquiry
• Forms: Usability Validation Tracking Matrix, Validation Protocol , and Validation Test Results Report will be given as Handouts

• Development Engineers
• Production Management
• QA/ QC Personnel
• Software Developers
• Engineering Management