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How to Conduct a Human Factors/ Usability Validation
- 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
Overview of the webinar
This webinar will explain the procedure described in ISO 62366, the FDA Guidance, and the new draft Guidance for a compliant human factors/ usability validation.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.
Who should attend?
- Development Engineers
- Production Management
- QA/ QC personnel
- Software developers
- Engineering management
Why should you attend?
Following the implementation of the reults of a Human Factors/ Usability 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.
Faculty - Mr.Edwin Waldbusser
Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the areas of design control, risk analysis and software validation for the past 8 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.