Course curriculum

    1. Welcome!

    2. Overall course learning objectives

    1. Learning objectives

    2. Why Usability Engineering (UE) matters

    3. The problem: Use error in medical devices

    4. Evolution of IEC 62366

    5. IEC 62366-1 and related standards

    6. Key definition: Use error (IEC 62366-1)

    7. Key definition: User interface (IEC 62366-1)

    8. Key definitions: Types of device use (IEC 62366-1)

    9. Key definition: Critical task (IEC 62366-1)

    10. The three components of HF/UE

    11. The core UE documents (IEC 62366-1)

    12. UE process overview

    13. Relationship to ISO 14971 risk management

    14. Integrating UE with Voice of Customer (VOC)

    15. Scaling Usability Engineering effort

    16. UE scaling considerations

    17. Usability Engineering Plan (UEP)

    18. SAMPLE DEVICE

    19. SAMPLE DEVICE - UE scope assessment

    20. SAMEPLE DEVICE - DQS ANSWERS

    21. QUIZ

    1. Learning objectives

    2. Use Specification purpose and scope

    3. Use Specification required elements (IEC 62366-1)

    4. Defining user populations

    5. User characteristics to consider

    6. Characterizing use environments

    7. Task Analysis

    8. Function Analysis

    9. SAMPLE DEVICE - Use Specification

    10. SAMPLE DEVICE - DQS ANSWERS

    11. QUIZ

    1. Learning objectives

    2. URRA purpose and content (FDA 2024 Guidance)

    3. URRA development process

    4. The Perception-Cognition-Action (PCA) model

    5. PCA model: Application in use error analysis

    6. Types of Use Errors

    7. Identifying critical tasks

    8. Example: Critical task identification

    9. Risk control hierarchy for use errors

    10. URRA table format (FDA example)

    11. SAMPLE DEVICE - URRA

    12. SAMPLE DEVICE - DQS ANSWERS

    13. QUIZ

    1. Learning objectives

    2. ANSI/AAMI HE75:2025 overview

    3. General HFE design principles (HE75)

    4. Control design principles (HE75 Section 18)

    5. Visual display design (HE75 Section 19)

    6. Alarm design principles (IEC 60601-1-8)

    7. User documentation & labeling (HE75 Section 11)

    8. SAMPLE DEVICE - HF Design principles

    9. SAMPLE DEVICE - DQS ANSWERS

    10. QUIZ

    1. Learning objectives

    2. Formative Evaluation purpose

    3. Goals of Formative assessment

    4. Formative Evaluation methods

    5. Formative vs. Summative Evaluation

    6. Planning Formative Evaluations

    7. Include challenge cases in Formative studies

    8. Formative study execution best practices

    9. Determining readiness for Summative

    10. SAMPLE DEVICE - Formative Evaluations

    11. SAMPLE DEVICE - DQS ANSWERS

    12. QUIZ

About this course

  • $2,500.00
  • 129 lessons
  • 0.5 hours of video content
  • Downloadable content

Usability Engineering (UE) and Human Factors (HF)

UE and HF apply scientific knowledge of human behavior, capabilities, and limitations to medical device design, ensuring safe, effective, and satisfying use throughout the product lifecycle.

  • Understand regulatory context, terminology, and relationship between IEC 62366-1, ISO 14971, FDA guidance, and ANSI/AAMI HE75.

  • Create and maintain Use Specifications, Use-Related Risk Analyses (URRA), and Usability Engineering Files (UEF).

  • Apply the Perception-Cognition-Action (PCA) model to identify Use Errors and implement effective risk controls.

  • Plan and execute Formative Evaluations to iteratively improve UI design throughout development.

  • Design and conduct Human Factors Validation testing/Summative Evaluations with appropriate participants and acceptance criteria.

  • Apply ANSI/AAMI HE75 design principles for controls, displays, alarms, labeling, and user documentation.

  • Integrate Usability Engineering with Design & Development, Risk Management, and Post-Market Surveillance.

  • Anticipate auditor expectations, avoid common deficiencies, and demonstrate systematic UE to regulatory bodies.

Discover your potential, starting today