IT: How to Conduct a Human Factors/ Usability Validation
Human Factors,Engineering, IT,Development,Software engineering
NetZealous LLC
Summary
- Certificate of completion - Free
- Tutor is available to students
Overview
This webinar will explain the procedure described in ISO62366 and the 2016 FDA 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.
Description
Why you should 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.
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. handouts areusability 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 is this course for?
- Development Engineers
- Production Management
- QA/ QC personnel
- Software developers
- Engineering management
Questions and answers
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Certificates
Certificate of completion
Digital certificate - Included
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Legal information
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