How to Conduct a Human Factors/ Usability Validation

  • Speaker:Edwin Waldbusser
  • Date: 17th April 2018 10:00 AM PST | 01:00 PM EST
  • Duration:60Min
  • Product Code:GRC-90287

$269

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Live Session - How it works

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Recorded Session - How it works

  • Login Information with Password to access the webinar recording will be emailed to you within 48 hours from the date the Live webinar was completed. The link to the recording is valid for 6 months.
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  • Presentation and other handouts will be emailed to you in a pdf format.

Training CD/ USB - How it works

The order will be processed within 2 working days from the date the webinar was completed. The presentation and other handouts will be emailed to you in a pdf format if we are unable to attach them in the CD or USB.

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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

Recording: Access the training Recording for 6 months from any location

$269

CD: Shipped within 2 working days

$389

USB - Shipped within 2 working days

$409

5 Member Group + Recording: 5 can Attend Live Meeting Online from any location globally + access to the training recording

$2,549

10 Member group + Recording: 10 can Attend Live Meeting Online from any location globally + access to the training recording

$3,569
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