Advanced Risk Management for Medical Devices (ISO 14971:2019) Fundamentals Training by Tonex
Navigating today’s medical device landscape demands fluency in ISO 14971:2019, evidence-based risk decisions, and seamless integration with PMS and CAPA. This program elevates practitioners from compliance to mastery—linking risk analysis, benefit–risk valuation, and data-driven control selection with clear traceability. Cybersecurity matters deeply because connected devices expand the attack surface, amplifying harm severity and exploit likelihood. We translate cyber threats into measurable hazard sequences and residual risk metrics. You will learn to embed cybersecurity requirements into risk files, align with IEC 62304/82304-1 touchpoints, and operationalize post-market detection of cyber signals alongside clinical and usability inputs.
Learning Objectives
- Apply ISO 14971:2019 end-to-end from risk planning through production and post-production
- Quantify benefit–risk trade-offs using data, models, and uncertainty bounds
- Operationalize links between risk controls, verification evidence, and CAPA effectiveness checks
- Integrate PMS signals into iterative risk evaluation and change control
- Build AI-assisted risk prediction pipelines with transparent assumptions and monitoring
- Map software lifecycle artifacts to the risk file for audit-ready traceability
- Strengthen device safety by treating cybersecurity as a hazard source and embedding controls across design, production, and PMS
Audience
- Regulatory Affairs Specialists
- Quality and Compliance Managers
- Risk Management Engineers
- R&D and Systems Engineers
- Clinical and Post-Market Surveillance Teams
- Product Managers and Leaders
- Cybersecurity Professionals
Program Modules
Module 1 – ISO 14971 Mastery
- Risk management plan essentials
- Hazard identification frameworks
- Sequence of events modeling
- Harm severity and probability
- Risk acceptability matrices
- Residual risk and disclosure
Module 2 – Benefit–Risk Evaluation
- Clinical benefit characterization
- Utility and multi-criteria scoring
- Uncertainty and sensitivity tests
- Socioeconomic considerations
- Patient-centric risk tolerance
- Documentation for reviewers
Module 3 – Data-Driven Risk Controls
- Design controls selection logic
- Detection versus prevention balance
- Verification and effectiveness metrics
- Traceability to requirements
- Human factors risk links
- Production and service controls
Module 4 – Cybersecurity as Safety
- Threats as hazard sources
- Secure architecture patterns
- SBOM and vulnerability intake
- Patch, update, change control
- Anomaly detection in PMS feeds
- Coordinated disclosure readiness
Module 5 – AI-Assisted Prediction
- Risk features and data pipelines
- Model selection and validation
- Bias, drift, and monitoring rules
- Explainability for decisions
- Thresholds and action triggers
- Evidence retention for audits
Module 6 – PMS and CAPA Integration
- Signal detection and triage
- Trending and statistical alerts
- Root cause and containment
- Corrective action effectiveness
- Updating risk files and IFU
- Management review and reporting
Advance your team’s capability to turn ISO 14971:2019 into a living system that unites safety, quality, and cybersecurity. Enroll now to build audit-ready risk files, defensible benefit–risk decisions, and a resilient PMS–CAPA engine that keeps your devices trusted in the market.