How to Conduct a Human Factors/ Usability Validation

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
Instructor:
Edwin Waldbusser
Date:
Wednesday, June 24, 2020
Time:
10:00 AM PDT | 01:00 PM EDT
Duration:
60 Minutes

More Trainings by this Expert   Product Id : 503148

Price Details
$150 Live
$290 Corporate Live
$190 Recorded
$390 Corporate Recorded
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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 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.

Why should you 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 Will Benefit:
  • Development Engineers
  • Production Management
  • QA/ QC personnel
  • Software developers
  • Engineering management


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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