Usability Engineering According to DIN EN 62366 1: Ensuring the Safe Use of Medical Devices

Introduction to Usability Engineering

• Fundamentals of usability engineering
• Distinction between usability and ergonomics
• Understanding the philosophy behind usability for medical devices

Regulatory Requirements

• MDR requirements for reducing use related risks
• FDA expectations for human factors engineering
• International regulatory landscape

Usability Engineering Process

• Usability engineering according to IEC 62366-1
• FDA’s human factors engineering process
• Integration into the development lifecycle
• Interfaces to risk management according to ISO 14971

Evaluation Methods

• Planning and conducting formative evaluations
• Planning and conducting summative (validation) evaluations
• Selecting appropriate methods and techniques
• Handling user interfaces of unknown origin

Risk Management and Safety

• Understanding the link between use errors and hazardous situations
• Safety related aspects of user interface design
• Relationship between IEC 60601-1-6 and IEC 62366-1

Documentation Requirements

• Required usability engineering documentation
• Evidence for regulatory submissions
• Traceability between usability, risk management, and design inputs

International Requirements

• FDA guidance “Applying Human Factors and Usability Engineering to Medical Devices”
• Key differences and similarities to IEC 62366-1
• Practical implications for global product development

• Medical device manufacturers
• Developers of medical software
• Regulatory Affairs managers
• Quality Management representatives
• Product managers
• Risk managers
• Marketing specialists

Why You Should Attend

This course is ideal for professionals who need a clear and actionable understanding of usability engineering for medical devices. It equips participants to implement usability processes effectively, integrate human factors into development, and generate compliant documentation for MDR and FDA submissions. Practical examples and optional hands on sessions help participants apply methods confidently and improve the safety and usability of their products.