IEC 62366-1 — Usability Engineering for Medical Devices Essentials Training by Tonex
Master the essentials of IEC 62366-1 to build medical devices that are intuitive, safe, and compliant across the product life cycle. You’ll translate user needs into verifiable design inputs, mitigate use errors with robust risk controls, and generate audit-ready usability files.
Because connected devices expand the attack surface, we also align human factors with secure-by-design practices so misuse cannot become a pathway to compromise. Clear user interfaces reduce workarounds, which lowers cybersecurity exposure and supports secure clinical workflows. You’ll leave with practical patterns to integrate usability activities into quality systems, accelerate approvals, and sustain post-market safety.
Learning objectives
- Apply IEC 62366-1 processes from planning to post-market
- Convert user research into measurable design inputs
- Build task analyses, UFMEA, and risk-control linkages
- Design and validate formative and summative studies
- Create compliant usability engineering files for audits
- Collaborate across RA/QA, engineering, and clinical teams
- Strengthen patient safety with traceable risk mitigations
Audience
- Product Managers
- Human Factors Engineers
- Systems and UX Engineers
- Regulatory and Quality Professionals
- Clinical Affairs and Risk Managers
- Cybersecurity Professionals
Course modules
module 1 — Foundations
- Standard scope
- Key definitions
- Process overview
- Roles and RACI
- Deliverable map
- Compliance pathways
module 2 — User Research
- Stakeholder mapping
- Context of use
- Task analysis
- Use scenarios
- Critical tasks
- Data capture
module 3 — Risk Integration
- Hazard taxonomy
- UFMEA drafting
- Severity/probability
- Risk controls
- Residual risk
- Traceability links
module 4 — Design Controls
- Requirements writing
- Interface principles
- Prototyping methods
- Information architecture
- Labeling and IFU
- Training materials
module 5 — Evaluation
- Formative studies
- Summative testing
- Sample sizing
- Metrics selection
- Observation methods
- Evidence synthesis
module 6 — Post-Market
- Complaint trends
- CAPA feedback
- Change control
- Vigilance inputs
- Field monitoring
- File maintenance
Ready to embed world-class usability and security into your next device? Enroll in Tonex’s IEC 62366-1 Essentials Training to accelerate compliance, reduce risk, and deliver safer, more trusted products to market.