Risk Management and ISO 14971 Essentials Training by Tonex
Modern medical technology succeeds when risk is anticipated, quantified, and continuously reduced. This program turns ISO 14971 from a compliance checkbox into a practical, end-to-end risk management system spanning concept, design, verification, release, and lifecycle feedback.
You will link hazards to patient harm, select fit-for-purpose controls, and build defensible documentation that satisfies regulators and auditors. Because connected devices expand the attack surface, we also map cyber threats into safety risks, hardening designs and processes. Clear guidance is provided to embed cybersecurity into risk files, align with IEC 62304/81001-5-1, and protect patients, data, and operations across the device lifecycle.
Learning Objectives:
- Apply ISO 14971 to structure risk management from concept through retirement
- Perform FTA, FMEA, and PHA with traceability to harms and controls
- Quantify risk using severity/probability and derive risk-control options
- Document benefit–risk decisions that withstand regulatory scrutiny
- Operationalize production and post-production monitoring with metrics
- Integrate usability engineering, software safety, and clinical inputs
- Embed cybersecurity into the risk file and justify cybersecurity residual risk
Audience:
- Regulatory and Quality Managers
- Risk Management and Safety Engineers
- Systems and Software Engineers
- Clinical Affairs and Post-Market Teams
- Product and Program Managers
- Auditors and Compliance Specialists
- Cybersecurity Professionals
Course Modules:
Module 1 – ISO 14971 Foundations and Scope
- Key definitions and principles
- Process, plan, and interfaces
- Regulatory expectations globally
- Roles, responsibilities, ownership
- Risk acceptability criteria
- Records, reviews, and audits
Module 2 – Risk Analysis Methods in Practice
- Preliminary hazard analysis (PHA)
- Failure modes and effects (FMEA)
- Fault tree analysis (FTA)
- Hazard identification techniques
- Detectability and diagnostic coverage
- Linking hazards to harms
Module 3 – Risk Evaluation and Controls
- Severity and probability scales
- Risk estimation and matrices
- Control hierarchy and selection
- Design, protective, information controls
- Verification of control effectiveness
- Assessing residual risk acceptability
Module 4 – Benefit Risk Evaluation and Documentation
- Clinical benefits and value claims
- Consolidating residual risks
- Overall residual risk acceptability
- Rationale and documented justifications
- Risk management report structure
- Alignment with submission dossiers
Module 5 – Production and Post Production Feedback
- Manufacturing data and in-process trends
- Field performance and complaint data
- PMS signals and vigilance inputs
- Trigger criteria and CAPA linkage
- Trending, metrics, and thresholds
- Feedback into design and labeling
Module 6 – Cybersecurity Risk for Medical Devices
- Threat modeling for safety impact
- Mapping cyber hazards to harms
- SBOM, patching, and update strategy
- Secure-by-design requirements tracing
- Monitoring, incident response hooks
- Justifying cybersecurity residual risk
Advance beyond compliance and build a resilient, audit-ready risk management system that protects patients and your brand. Enroll your team in Tonex’s Risk Management and ISO 14971 Essentials today to operationalize FTA, FMEA, and PHA, strengthen benefit–risk justifications, and close the loop with production and post-production evidence.