How to Conduct a Human Factors/ Usability Validation

  • Speaker:Edwin Waldbusser
  • Date: 17th October 2018 10:00 AM PST | 01:00 PM EST
  • Duration:60Min
  • Product Code:GRC-90396

$169

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If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com.

Description:

This webinar will explain the procedure described in ISO 62366 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 must 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. handouts are usability 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 

Handouts:

Usability Validation Tracking Matrix, Validation Protocol and Validation Test Results Report will be given as Handouts 

Who will benefit:

  • Development Engineers
  • Production Management
  • QA/ QC personnel
  • Software developers
  • Engineering management
  • Medical Device Industries

Instructor:

Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting internationally in the areas of design control, risk analysis and software validation for the past 9 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.

Available Options

Live Meeting Access Single: Attend the Live Meeting Online from any location

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2 Single Live Access: 2 people can attend the meeting Live from any location

$279

Recording: 6 Months Access to the Training which can be accessed from any location

$249

CD-DVD: Shipped within 2 working days

$349

USB - Shipped within 2 working days

$389

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Live + CD: Attend Live Meeting Online + Get the training CD shipped for free

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Live + USB - Attend Live online + Get the training USB shipped for free

$409

5 Member Group: 5 people can Attend the Live Online Meeting from any location globally

$539

10 Member Group: 10 people can Attend the Live Online Meeting from any location globally

$839

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