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Keep shoppingHuman Factors and Usability Engineering in Medical Devices
156 students
Human Factors and Usability Engineering in Medical Devices
Ensuring FDA Compliance and User-Centered Design
Created byeQMS Innovation
Last updated 2/2025
English
What you'll learn
- Understand FDA & Global Regulatory Requirements
- Learn how FDA, IEC 62366-1, ISO 14971, regulate Human Factors Engineering and usability testing in medical device development.
- Integrate Human Factors into Risk Management
- Identifying use-related hazards, critical tasks, and risk control measures
- Develop and Execute Usability Testing Plans
- Apply human-centered design principles to create medical device interfaces
- Prepare FDA-Compliant Usability Documentation
Explore related topics
Course content
2 sections • 10 lectures • 1h 48m total length
Requirements
- Basic Understanding of Medical Devices and Regulations – Familiarity with medical device development, FDA, EU MDR, or ISO 13485 is helpful but not required. The course will introduce key regulatory aspects of Human Factors and Usability Engineering.
- Interest in Risk Management and Usability – A general understanding of risk management concepts (ISO 14971) and how medical devices interact with users can enhance learning but is not mandatory.
- No Special Software or Tools Required – Learners only need a computer with internet access. Templates and guidance on usability testing tools (e.g., usability studies, and task analysis, formative and summative evaluations) will be provided.
- Open to All Professionals – Ideal for engineers, regulatory specialists, quality assurance professionals, UX/UI designers, and healthcare professionals involved in medical device development.
Description
Medical device usability plays a critical role in patient safety, regulatory approval, and market success. Poor usability can lead to user errors, device misuse, and regulatory rejections, increasing risks for both patients and manufacturers. This course provides a comprehensive, step-by-step guide to Human Factors and Usability Engineering (HFE/UE), ensuring compliance with US FDA, EU MDR, IEC 62366-1, and ISO 14971.
You will learn how to apply usability engineering principles to medical device design, conduct formative and summative usability testing, and integrate Human Factors into risk management. The course covers regulatory expectations, risk-based usability design, user interface (UI) design best practices, and usability documentation for regulatory submissions.
Whether you’re a medical device engineer, regulatory professional, UX designer, or clinician, this course will equip you with the skills and tools to optimize device usability, reduce user errors, and ensure FDA, EU MDR compliance.
What You Will Learn:
Apply Human Factors Engineering (HFE) principles in medical device development
Applying Human Factors Engineering (HFE) Principles in AI and Software as a Medical Device (SaMD)
Ensure compliance with US FDA, EU MDR, IEC 62366-1, and ISO 14971 usability requirements
Conduct task analysis, usability risk assessments, and usability testing
Design intuitive, safe, and user-friendly medical devices
Prepare Human Factors documentation for regulatory submissions
Enroll now and take your medical device usability expertise to the next level!
Who this course is for:
- Medical Device Engineers & Designers – Learn how to apply usability engineering principles to optimize device design, minimize user errors, and enhance patient safety.
- Regulatory & Quality Professionals – Understand how Human Factors and Usability Engineering fit into ISO 13485, FDA submissions, EU MDR, and risk management to meet compliance requirements.
- Human Factors Specialists & UX/UI Designers – Gain insights into task analysis, usability testing, and user interface (UI) design for medical devices.
- Healthcare Professionals & Clinicians – Enhance your understanding of how medical devices are designed for safety and efficiency, providing feedback that improves usability.