How to Conduct a Human Factors/Usability Validation
Edwin Waldbusser is a consultant who retired from the industry after 20 years in management of the development of medical devices (5 patents). He has been consulting internationally in the areas of design control, risk analysis, and software validation for the past 9 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.
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.
- 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
Course Level - Basic Through Advanced.
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 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.