1. Summary of the Human Factors Engineering Process – End to End
2. Preparing a Use Specification
3. Description of the Device User Interface
4. Summary of Known Use Problems
5. Analysis of Hazards and Risks Associated with Use
6. Summary of Preliminary Analyses and Evaluations
7. Formative and Summative (Validation) Testing
9. Residual Risk Analysis
10. Hands-on training on Use Related Risk Analysis

Those who work in the development of medical devices or combination products:

• Human factors engineers
• Regulatory affairs personnel
• Quality Assurance (QA) specialists
• Product managers
• Medical Device Engineers

• Engineering process – Gain an end‑to‑end understanding of the Human factors engineering process and how each portion of the usability-engineering file supports regulatory submissions and the overall usability of the product
• Usability documentation – Reduce usability expenses by learning to write key sections of usability documentation effectively
• Use‑Related Risk Analysis – Gain the ability to independently prepare a Use‑Related Risk Analysis (URRA) table
• Human factors validation – Understand when human factors validation testing may or may not be required based on regulatory expectations
• Harmonize FDA and NB – Learn how to harmonize FDA and NB usability documentation into one aligned regulator‑ready package
• Gain insights from real examples, common pitfalls, and best practices used in successful submissions