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  • On-demand Webinar

Design Changes after HF Validation: How to Assess a Change's Impact and Need for Supplemental Testing

Discover how to assess the impact of post-validation design changes to medical devices and determine when supplemental human factors (HF) testing may be needed in this on-demand webinar.

Concord usability lab device critique of pen injectors

Watch now: How to assess a change's impact and need for supplemental testing

The experts from Emergo by UL’s Human Factors Research & Design team walk through how to assess the impact of changes implemented after HF validation testing and determine whether supplemental testing is necessary.

Webinar date

July 30, 2025

Speakers

Laura Birmingham, Associate Research Director
Stephanie Larsen, Managing Human Factors Specialist

Group of colleagues collaborating in front of a bulletin board

Uncovering usability issues

It is common for HF validation testing to uncover usability issues, especially with critical tasks, leading to some common questions:

  • Can we modify the design post-validation?
  • Will those changes require further HF testing?
  • What testing will need to be conducted?

In this webinar, we cover

Residual risk analysis

Describe the use of residual risk analysis in determining the need for changes following HF validation testing.

Post-validation changes

Explain the nuances of determining whether post-validation changes might require additional HF validation testing.

Scope

Provide insight into how to scope a supplemental HF validation test based on the type and extent of changes.

Additional HF validation testing

Clarify what changes are more likely to require additional HF validation testing, and how to assess these changes.

 

Related software

Explore our human factors software platform, OPUS™

OPUS offers a wide variety of training, tools, templates and regulatory guidance to help you stay ahead in your HFE activities.

Learn more

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