About this event
$150 Individual Workshop Admission
︎ 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