How to Conduct a Human Factors Validation Test Following ISO62366 and the FDA Guidance

Duration: 60 Minutes
Validation testing aims to show that a device can be used by the intended users without serious use errors or problems, for the intended uses and under the expected use conditions. This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for a compliant human factors/ usability validation test. 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.
Human Factors Validation Test
Instructor: Edwin Waldbusser
Product ID: 502041
Objectives of the Presentation
  • Required number of participants
  • Qualitative success criteria
  • Choice of tasks to validate
  • Post test participant inquiry
  • Validation
  • Step by step human factors validation test development
Why Should you 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.

Who will Benefit
  • Engineer
  • Engineering Manager
  • Regulatory Personnel
  • Development Engineers
  • Production Management
  • QA/QC Personnel
  • Software Developers
  • Usability engineers
  • Risk managers
  • Design Engineering Managers
$375
Recorded Session for one participant
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  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
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Instructor Profile:
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, 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.
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