Usability Engineering and Human Factors (IEC 62366) Fundamentals Training by Tonex
This course provides a deep understanding of usability engineering and human factors in compliance with IEC 62366. Participants learn essential principles, regulatory requirements, and best practices for designing user-friendly medical devices. The training covers risk management, usability testing, and documentation strategies. It explores human-centered design, error reduction, and safety considerations. By the end of the course, attendees will be equipped to improve product usability, enhance user experience, and ensure regulatory compliance.
Audience:
- Medical device designers
- Quality assurance professionals
- Regulatory affairs specialists
- Human factors engineers
- Product development teams
- Compliance officers
Learning Objectives:
- Understand usability engineering and IEC 62366 principles
- Learn human factors’ role in medical device design
- Identify risk management strategies for usability
- Conduct usability testing and user evaluations
- Develop usability documentation for compliance
Course Modules:
Module 1: Introduction to Usability Engineering and IEC 62366
- Overview of usability engineering principles
- Importance of human factors in medical devices
- Regulatory framework and IEC 62366 compliance
- Key usability challenges in healthcare products
- Human-centered design and its impact
- Role of usability in product safety
Module 2: Human Factors and Risk Management
- Understanding human error and its implications
- Risk analysis in usability engineering
- Hazard-related usability factors
- Techniques for identifying usability risks
- Mitigating usability-related design issues
- Integrating usability into risk management
Module 3: Usability Testing and Evaluation Methods
- Fundamentals of usability testing
- Planning and conducting user evaluations
- Data collection and interpretation techniques
- Iterative design and feedback incorporation
- Common usability testing challenges
- Improving product design through evaluation
Module 4: User Interface Design and Optimization
- Principles of intuitive user interfaces
- Cognitive load and decision-making factors
- Layout and visual design considerations
- Enhancing accessibility and user experience
- Best practices for interactive elements
- Addressing usability challenges in device interfaces
Module 5: Documentation and Compliance Requirements
- Usability engineering file essentials
- Regulatory expectations for documentation
- Creating effective usability reports
- Traceability in usability design processes
- Demonstrating compliance through documentation
- Common pitfalls in usability documentation
Module 6: Implementation and Continuous Improvement
- Integrating usability into development cycles
- Training teams on human factors principles
- Monitoring and improving usability post-market
- Addressing feedback and usability concerns
- Adapting to evolving usability standards
- Future trends in usability engineering
Enhance your expertise in usability engineering and human factors. Enroll today to ensure compliance and improve user experience!