Human Factors and Usability Studies following ISO 62366 and FDA QMSR

Overview:

Medical device companies cannot afford to treat usability problems as minor issues that can be fixed late in development. When users misunderstand instructions, struggle with controls, or use a device differently than intended, the result can affect safety, performance, and regulatory confidence. Human factors and usability engineering help manufacturers study those interactions early, identify where use-related problems may arise, and make design decisions that reduce those risks.

FDA’s approach to human factors places attention on how intended users actually interact with a device in real-world conditions. That includes examining user characteristics, use environments, interface design, critical tasks, and the points where confusion or misuse could create harm. For manufacturers, this means human factors work must be connected to risk analysis, design decisions, evaluation activities, and validation planning throughout the product lifecycle.

This topic is especially relevant under the current QMSR framework, where risk-based thinking is expected across quality system processes and where information generated in one part of development should support decisions in others. Human factors findings should feed into design reviews, risk management, validation activities, and the documentation needed to support a well-controlled development process.

In this webinar, attendees will learn how to develop a practical human factors and usability program aligned with ISO 62366, FDA expectations, and current QMSR thinking. The session will cover user profiles, use scenarios, use-related hazards, use-related risk analysis, step-by-step program development, validation planning, and the documentation needed to support a clear and well-integrated approach.

Areas covered in the session:

• User error versus use error
• Use related hazards and risk analysis
• URRA
• User profiles
• Use scenarios
• Step by step human factors program development
• Human Factors validation

Handouts Included:

• Use-Related Risk Analysis Scenario Playbook
• Usability Validation Protocol and Observation Pack
• Human Factors Traceability and QMSR Documentation Toolkit

Why Should You Attend?

Human factors and usability work can influence far more than product design alone. When use-related risks are not properly identified, studied, and addressed, the result can create problems in validation, submissions, design reviews, and broader quality system activities. This session will help you understand how to approach usability in a way that supports both safer device design and stronger regulatory preparedness.

This webinar is especially useful for teams that need practical clarity on how ISO 62366, FDA human factors expectations, and QMSR-related quality system thinking fit together. Rather than treating usability as a separate exercise, the session will show how it connects with risk analysis, user interface assessment, documentation, and validation planning throughout development.

You should attend if your organization needs a clearer, more structured approach to human factors studies and the records that support them. Whether you are building a new program or strengthening an existing one, this webinar will help you see what needs to be evaluated, what needs to be documented, and how to make the work more useful across the product development and quality process.

Who will benefit?

This webinar is designed for professionals who are directly involved in usability engineering, risk analysis, design control, validation, and regulatory review for medical devices. It will be especially useful for teams that need human factors work to hold up in development records, submissions, and quality system processes; those include

• Human Factors Engineers
• Usability Engineers
• Human Factors / Usability Validation Specialists
• Human Factors Study Leads
• Design Assurance Engineers
• Design Control Specialists
• Risk Management Specialists
• ISO 14971 / Risk Analysis Engineers
• Product Development Engineers
• R&D Engineers for Medical Devices
• Systems Engineers
• User Interface / Device Interface Design Leads
• Verification and Validation Engineers
• Design Quality Engineers
• Quality Assurance Managers
• Quality Engineers supporting design and development
• Regulatory Affairs Specialists
• Regulatory Affairs Managers
• Medical Device Project Managers
• Cross-functional design and development leads responsible for submission-ready documentation