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Faculty: José Mora

  • Date: 1/18/2022 01:00 PM - 1/18/2022 02:00 PM
  • Time zone: Eastern Time (US/Canada) Online Event


This webinar will explain the procedure described in ISO62366 and the 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 You Should 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 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.

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
  • Validation Test Results Report will be given as Handouts

Who Should Attend:

  • Development Engineers
  • Production Management
  • QA/QC Personnel
  • Software Developers
  • Usability engineers
  • Risk managers
  • Design Engineering Managers