Certified Usability Engineer for Medical Devices (CUEMD)

Certified Usability Engineer for Medical Devices (CUEMD) Certification Program by Tonex

This program prepares professionals to design, assess, and validate medical devices that are safe, effective, and intuitive across clinical and home settings. Participants learn human factors engineering, usability risk management, formative and summative evaluation techniques, and documentation aligned with regulatory expectations for medical technology.

The curriculum emphasizes end-to-end design controls, traceability from hazards to mitigations, and evidence generation for verification and validation. Cybersecurity is addressed as a core dimension of safety and usability, covering secure workflows, alerts, and data handling that reduce user error. Participants examine how cybersecurity decisions influence cognitive load, alarm design, and recovery from unsafe states to ensure resilient user experiences throughout the device lifecycle.

Learning Objectives

• Apply human factors engineering to medical device design
• Build usability risk analyses linked to design controls
• Plan and execute formative and summative usability studies
• Translate user needs into measurable usability requirements
• Generate verification and validation evidence for regulators
• Integrate cybersecurity considerations that improve safe use and reduce user error
• Produce compliant usability engineering files and reports

Audience

• UX and Human Factors Engineers
• Regulatory Affairs Specialists
• Quality and Risk Management Professionals
• Product Managers and Systems Engineers
• Clinical Specialists and Biomedical Engineers
• Cybersecurity Professionals

Course Modules

Module 1: Usability Risk Management Foundations

• Regulatory scope and expectations
• Hazard identification techniques
• Use error taxonomy and coding
• Severity, occurrence, detectability
• Risk controls and mitigations
• Traceability to verification

Module 2: Human Factors Engineering Process

• Context of use analysis
• User and stakeholder profiling
• Task analysis and workflow mapping
• Use scenarios and critical tasks
• Cognitive load and error traps
• Iterative design and refinement

Module 3: Requirements and Design Controls

• Usability requirements drafting
• Acceptance criteria and metrics
• Design inputs and outputs
• Interface specifications linkage
• Change control and rationale
• Documentation best practices

Module 4: Formative Evaluation and Prototyping

• Planning formative studies
• Protocols and facilitator guides
• Rapid prototyping approaches
• Moderation and observation skills
• Data capture and quick synthesis
• Iteration and decision records

Module 5: Summative Validation and Reporting

• Validation readiness criteria
• Sample size and participant mix
• Test environment and realism
• Success criteria and statistics
• Root cause analysis of errors
• Final reporting and justifications

Module 6: Cybersecurity and Safe Use Integration

• Secure-by-design usability patterns
• Authentication with minimal burden
• Alarm, alert, and message design
• Secure updates and incident recovery
• Data privacy in clinical workflows
• Postmarket monitoring and feedback

Exam Domains

1. Usability Risk Analysis and Control
2. Human Factors Methods and Tasks
3. Requirements, Metrics, and Traceability
4. Formative Study Design and Synthesis
5. Summative Validation and Evidence
6. Secure Use and Postmarket Surveillance

Course Delivery
The course is delivered through a combination of lectures, interactive discussions, hands-on workshops, and project-based learning, facilitated by experts in the field of Certified Usability Engineer for Medical Devices. Participants will have access to online resources, including readings, case studies, and tools for practical exercises.

Assessment and Certification
Participants will be assessed through quizzes, assignments, and a capstone project. Upon successful completion of the course, participants will receive a certificate in Certified Usability Engineer for Medical Devices.

Question Types

• Multiple Choice Questions (MCQs)
• Scenario-based Questions

Passing Criteria
To pass the Certified Usability Engineer for Medical Devices Certification Training exam, candidates must achieve a score of 70% or higher.

Ready to elevate device safety and user trust? Enroll now in CUEMD by Tonex and build validated, secure, and truly usable medical technologies.