How To Conduct A Human Factors/Usability Validation
Duration : 60 Minutes
Jose Mora,
Jose Mora, is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences industry specializing in manufacturing, process development, tooling, and quality systems. Prior to working full time as a consulting partner for Atzari Co Read more
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.
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. 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.
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 Should Attend:
• Development Engineers
• Production Management
• QA/QC Personnel
• Software Developers
• Usability engineers
• Risk managers
• Design Engineering Managers
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
100% MONEY BACK GUARANTEED
Refund / Cancellation policyGet In Touch
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