ISO 14971: Application of Risk Management to Medical Devices Essentials Training by Tonex
Regulators expect more than paperwork—they expect a defensible, risk-driven lifecycle. This course gives medical device teams a practical, end-to-end path to apply ISO 14971 with confidence from concept through post-market surveillance. You’ll translate standards into daily decisions, align clinical benefit with risk controls, and generate evidence that stands up to audits. Because connected and software-enabled devices expand the attack surface, we also address how risk management intersects with cybersecurity, threat modeling, and secure post-market updates. You will learn to integrate safety and cybersecurity risk files, prioritize controls, and communicate risk–benefit rationales to engineering and quality leadership.
Learning Objectives
- Apply ISO 14971 across planning, analysis, evaluation, control, and review
- Build traceable risk files that satisfy auditors and notified bodies
- Translate hazards, sequences of events, and harms into measurable risks
- Select and verify risk controls; evaluate residual risk and benefit–risk
- Orchestrate risk management with design controls and PMS/PSUR inputs
- Integrate cybersecurity risk into safety risk assessments using common frameworks and maintain cybersecurity evidence throughout the lifecycle
Audience
- Product Managers and Owners
- Systems and Design Engineers
- Quality and Regulatory Affairs Professionals
- Clinical and Safety Specialists
- Cybersecurity Professionals
- Post-Market and Vigilance Teams
- Start-up Founders and R&D Leaders
Course Modules
Module 1 – ISO 14971 Foundations
- Scope, key terms, and principles
- Roles and lifecycle alignment
- Risk management plan contents
- Defining intended use and misuse
- Interfaces with 13485 and 62366
- Documentation and governance
Module 2 – Hazard Analysis Methods
- Hazard identification techniques
- Sequences of events modeling
- P1/P2 probability considerations
- Severity, harm, and clinical context
- Software/AI-specific hazards
- Use error and usability inputs
Module 3 – Risk Evaluation and Controls
- Risk acceptability matrices
- Selecting control options hierarchy
- Design vs. protective measures
- Information for safety labeling
- Traceability from hazard to control
- Verification of control effectiveness
Module 4 – Residual Risk and Benefit–Risk
- Aggregating residual risk evidence
- Benefit–risk justification structure
- Risk–benefit for software updates
- ALARP/AFAP interpretations
- Management review requirements
- Communicating decisions to stakeholders
Module 5 – Post-Market and Change Control
- PMS, PMCF, and vigilance signals
- Complaint trending and triggers
- Field safety corrective actions
- Risk file maintenance with changes
- Cybersecurity monitoring and SBOMs
- Linking CAPA and risk updates
Module 6 – Documentation and Audit Readiness
- Anatomy of a robust risk file
- Templates, checklists, and records
- Evidence mapping to clauses
- Common auditor questions
- Cross-functional review cadence
- Continuous improvement roadmap
Ready to elevate risk management from a checkbox to a competitive advantage? Enroll your team in Tonex’s ISO 14971 Essentials today to build compliant, audit-ready risk files that integrate safety and cybersecurity—accelerating approvals and protecting patients.