How to Conduct a Human Factors/ Usability Validation
Duration : 60 Minutes
Edwin Waldbusser, Medical Device
Ed retired from industry after 30 years in management of development of medical device products and development of company Quality Systems. He was involved in the development of products such as IVD devices, kidney dialysis systems and inhalation devices. His QS experience includes, design control, risk analysis, CAPA, softwa Read more
When implementation of the results of a Human Factors/ Usability study are successful, human factors (HF) validation can be very straightforward. It is like checking off the boxes on a study protocol. But if all the pieces of implementation of the results of a Human Factors/ Usability study do not come together as planned, however, HF validation can be a complicated endeavor.
In this webinar expert speaker Edwin Waldbusser will explain the procedure described in ISO62366 and the 2016 FDA Guidance for a compliant human factors/ usability validation and will also discuss the documentation requirements. HF/U validation is very different from device validation. For example, success criteria is 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
Course Objectives:
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. This webinar will explain the FDA required number of validation participants from each "distinct user population". Speaker 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. Edwin will describe how to do this.
Course Outline:
• 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
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Development Engineers
• Production Management
• QA/ QC personnel
• Software developers
• Engineering management
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
100% MONEY BACK GUARANTEED
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