Risk and Safety Leadership Track: ISO 14971, Advanced Risk Management, Electrical Safety, Usability Fundamentals Training by Tonex
Leaders who steward regulated products need more than checklists—they need judgment, structure, and cross-functional influence. This course builds practical mastery across ISO 14971 risk management, advanced analysis techniques, electrical safety, and usability engineering so teams can ship safer products with confidence. Cyber-physical systems raise the stakes, so we connect product safety with security-by-design practices and supply-chain vigilance. You will learn how cybersecurity vulnerabilities can escalate safety risks and how to integrate coordinated controls into the risk file. We also map governance and culture levers that sustain outcomes long after audits, helping you lead with clarity under pressure.
Learning Objectives
- Apply ISO 14971 end to end from hazard identification through risk–benefit evaluation and post-market surveillance
- Select and execute advanced risk analysis methods proportionate to uncertainty and lifecycle stage
- Integrate usability engineering evidence to reduce use-related hazards and residual risk
- Interpret electrical safety requirements and design controls aligned to standards and test regimes
- Build governance, metrics, and culture that reinforce disciplined risk decisions across functions
- Translate safety cases into clear, auditable documentation that stands up to regulators and customers
- Connect safety and cybersecurity so that security controls reduce safety risk without creating new hazards
Audience
- Product and Safety Managers
- Quality and Regulatory Affairs Professionals
- Systems and Design Engineers
- Human Factors and Usability Specialists
- Electrical and Test Engineers
- Cybersecurity Professionals
- Project and Program Managers
Course Modules
Module 1 — ISO 14971 Essentials Alignment
- Risk management plan elements
- Hazard identification techniques
- Sequence of events modeling
- Risk evaluation criteria
- Risk control option analysis
- Post-market surveillance linkage
Module 2 — Advanced Hazard Analysis Methods
- FMEA and FMECA refinement
- Fault tree quantification basics
- Bowtie and barrier thinking
- Bayesian updating of risk
- Common cause failure review
- Sensitivity and uncertainty checks
Module 3 — Electrical Safety and Compliance
- Shock, burn, fire mechanisms
- Insulation and creepage rules
- Protective earth and leakage
- Protective devices selection
- Test strategies and evidence
- Regulatory marks and filings
Module 4 — Usability Engineering Fundamentals Practice
- Use specification scoping
- User research data synthesis
- Task analysis and scenarios
- Use error risk mapping
- Summative validation planning
- Labeling and IFU clarity
Module 5 — Risk Controls and Lifecycle
- Inherent safety by design
- Protective measures selection
- Information for safety tactics
- Verification and effectiveness
- Residual risk acceptability
- Change control and re-assessment
Module 6 — Leadership, Culture, and Governance
- Roles, RACI, and ownership
- KPIs and safety leading metrics
- Tiered reviews and escalation
- Audit-ready documentation flow
- Supplier and partner assurance
- Incident learning and feedback
Elevate your organization’s risk posture and lead with authority. Enroll your team in the Risk and Safety Leadership Track by Tonex to align safety, usability, electrical compliance, and cybersecurity into one decisive practice.