How to Conduct a Human Factors - Usability Validation Test following ISO 62366 and the 2016 FDA Guidance


  Duration: 60 Minutes  

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In this webinar speaker will explain how to choose the tests to be conducted and the studies that must be completed prior to the actual validation test.
Edwin Waldbusser   Product Id : 501818
  Instructor : Edwin Waldbusser

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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.

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.

Areas Covered in the Session:

  • Required number of Participants
  • Test Procedure
  • Qualitative Success Criteria
  • Choice of Tasks to Validate
  • Post test Participant Inquiry

Who Will Benefit:
  • Engineer
  • Engineering Manager
  • Regulatory Personnel
  • QA


Speaker Profile
Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the US and internationally in the areas of design control, risk analysis and software validation for the past 8 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.




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