Human Factors Engineering Workshop

About this event

$150 Individual Workshop Admission
︎ Online/Remote 
︎ January 18, 2023

Join UserWise Human Factors Engineer, Shrikar Tatapudi and Director, Denise Forkey for a 4-hour workshop on Human Factors for medical devices and combination products.

The workshop is offered as one-time online/remote program.

This workshop will provide an overview of the Human Factors Engineering process that should be utilized during medical product development and cover key topics to establish a baseline understanding of Human Factors and its place within product development. Additionally, we will review important concepts of usability risk management.

During this workshop, we will cover:
  • What is Human Factors Engineering, and why is it important
  • What is the user interface for a medical product
  • Key Human Factors Guidance, Standards, and Regulations in the U.S. and outside of the U.S.
  • Review of the Human Factors Engineering Process for Medical Products
  • When to implement Human Factors in the product development process
  • Early Stage Human Factors Research on Users / Use Environments / Context of Use
  • Overview of Use-Related Risk Analyses (URRA)
    • Key terminology and inputs to the process
    • Practical considerations when conducting use-related risk analysis (different ways to prepare a URRA, advantages and disadvantages of these approaches)
    • How use-related risk analyses fit into the greater picture and relate with Design FMEAs, Process FMEAs, and hazard analyses
    • Defining and determining severity levels and occurrences when conducting use-related risk analysis
  • Formative Usability Testing
  • Human Factors Validation Testing
  • Human Factors Documentation needed for Regulatory Submission
  • Key factors for tailoring the Human Factors Engineering Process

Event Registration

Remote Attendance - $150
Individual Workshop Admission

Wednesday, January 18

︎ Remote
︎ 9:00 AM - 1:00 PM PT

︎ Instructors: Denise Forkey & Shrikar Tatapudi

Meet Our Instructors


UserWise, LLC
Office Hours
Monday-Friday 9:00 AM - 5:00 PM PT

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