Engineering: Usability Validation Test following ISO 62366 and the 2016 FDA Guidance
Human Factors,Engineering,Construction ,Environmental 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 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.
Description
Why you should 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 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.
Areas Covered in the Session:
- Required number of Participants
- Test Procedure
- Qualitative Success Criteria
- Choice of Tasks to Validate
- Post test Participant Inquiry
Who is this course for?
- Engineer
- Engineering Manager
- Regulatory Personnel
- QA
Questions and answers
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Certificates
Certificate of completion
Digital certificate - Included
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Legal information
This course is advertised on reed.co.uk by the Course Provider, whose terms and conditions apply. Purchases are made directly from the Course Provider, and as such, content and materials are supplied by the Course Provider directly. Reed is acting as agent and not reseller in relation to this course. Reed's only responsibility is to facilitate your payment for the course. It is your responsibility to review and agree to the Course Provider's terms and conditions and satisfy yourself as to the suitability of the course you intend to purchase. Reed will not have any responsibility for the content of the course and/or associated materials.