BEST SELLER - Human Factors Validation Testing Following ISO 62366 and new FDA Guidance
Edwin Waldbusser retired from the industry after 30 years in management of the 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, software validation, supplier qualification/ control and manufacturing/non-conforming product programs. He now consults in the area of quality systems for medical devices with emphasis on design control, software validation, risk analysis and human factors analysis. Ed has a B.S. Mechanical Engineering from NYU and a M.B.A from Drexel University. He is certified by Lloyds of London as an ISO 9000 Lead Auditor and is a member of the Thomson Reuters Expert Witness network. He has 5 issued patents. He is also owner of www.meddeviceadvisors. com which offers over 80 easy to customize medical device Quality System SOP's.
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.
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.
Areas Covered
- Required number of participants
- Qualitative success criteria
- Choice of tasks to validate
- Post test participant inquiry
- Use scenarios
- Step by step human factors program development
- Validation
Who Should Attend
- QA/QC Personnel
- Manufacturing
- Development Engineers
- Production Management
- Software developers
- Engineering management
Why 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.
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$150.00
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