How to Conduct a Human Factors/ Usability Validation

  • Speaker:Edwin Waldbusser
  • Duration:60Min
  • Product Code:GRC-90396

Live Session - How it works

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  • Certificate of attendance is emailed to you within 6 working days from the date the webinar was completed. If you don’t receive an email within 6 days. Please email our support@grcts.com

Recorded Session - How it works

  • Login Information with Password to view the webinar will be emailed to you within 48 hours from the date the Live webinar was completed. The link to the recording is for a single person use only and it is valid for 6 months or the actual duration the recording was purchased.
  • Please click on the link to access the Recording and type in the password provided in the email.
  • Presentation and other handouts will be emailed to you in a pdf format.

Training CD - How it works

  • Free shipment 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.

(For more information about our products contact +1- 248-233-2049)

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 

Free Handouts to all Participants: 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: 6 Months Access to the Training which can be accessed from any location

$259

CD-DVD: Shipped within 2 working days

$389

USB - Shipped within 2 working days

$409

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

$3,249

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

$4,459

Recording Access to 10 Members: 10 Participants can access the training Recording for 6 months from any location

$829

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