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IT: How to Conduct a Human Factors/ Usability Validation

Human Factors,Engineering, IT,Development,Software engineering


NetZealous LLC

Summary

Price
£140 inc VAT
Or £46.67/mo. for 3 months...
Study method
Online
Duration
1 hour · Self-paced
Access to content
6 months
Qualification
No formal qualification
Certificates
  • Certificate of completion - Free
Additional info
  • Tutor is available to students

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.

Description

Why you should 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 is this course for?

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

Questions and answers

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Certificates

Certificate of completion

Digital certificate - Included

Reviews

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FAQs

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