ISO 14971 Cybersecurity Risk Management Workshop by Tonex
Elevate your medical device risk practice with a focused, implementation-ready workshop on ISO 14971. We connect risk management principles to real-world product lifecycle decisions, from early design choices and hazard analysis to production, postmarket surveillance, and field corrective actions. You will learn how to integrate usability, software, and supply chain considerations into a coherent risk file that stands up to audits and regulatory reviews. Cybersecurity plays a central role—attendees map threat scenarios to harms, trace controls through verification, and justify residual risk. You will also align security risk management with safety risk, ensuring consistent documentation and defensible acceptability criteria.
Learning Objectives
- Apply ISO 14971 terminology, concepts, and process flow end to end
- Build and maintain a compliant risk management file and risk plan
- Perform hazard identification, HAZOP-style analysis, and risk estimation
- Define risk controls, verification, and benefit–risk justifications
- Integrate production and postmarket data into continuous risk updates
- Align documentation with regulatory expectations and notified bodies
- Strengthen cross-functional collaboration and review workflows
- Quantify cybersecurity risk within ISO 14971 to demonstrate device safety and cybersecurity resilience
Audience
- Product Managers
- Systems and Safety Engineers
- Quality and Regulatory Affairs
- Risk and Compliance Leads
- Software and Firmware Engineers
- Cybersecurity Professionals
Course Modules
Module 1 – Foundations
- ISO 14971 scope and structure
- Terms, definitions, core roles
- Risk policy and acceptability
- Risk plan and responsibilities
- Interfaces with QMS processes
- Traceability across lifecycle
Module 2 – Hazard Analysis
- Hazard, sequence of events, harms
- Use-related and misuse scenarios
- Software and connectivity hazards
- Supply chain and SOUP impacts
- Environmental and EMC factors
- Data-driven hazard catalogs
Module 3 – Risk Estimation
- Severity and probability models
- Detectability and uncertainty
- Pre- and post-control estimates
- Evidence sources and priors
- Aggregating multi-hazard risk
- Visual risk matrices limits
Module 4 – Risk Control
- Inherent safety by design
- Protective measures selection
- Information for safety content
- Verification and effectiveness
- Benefit–risk justification
- Residual risk evaluation
Module 5 – Cybersecurity Integration
- Threat modeling to harms
- Security controls to safety
- SBOM and patch strategy
- Secure update and keying
- Anomaly and incident intake
- Postmarket security signals
Module 6 – File and Evidence
- Risk file architecture
- Change control and variants
- Production monitoring inputs
- CAPA and risk linkages
- Field data trending methods
- Audit-ready documentation
Ready to operationalize ISO 14971 with cybersecurity confidence and audit-ready evidence? Enroll now with Tonex to equip your team with practical methods, templates, and decision frameworks that accelerate compliant, safe, and secure medical devices.