Risk Management Specialist

ISO 14971:2019 risk management implementation throughout the medical device lifecycle — planning, hazard analysis, risk evaluation, risk control, residual-risk assessment, and post-production monitoring — extended for AI/ML, cybersecurity (IEC 81001-5-1), supply chain, and cross-framework alignment (NIST CSF, DORA, NIS2).

Core Capabilities

• Risk management planning — scope, 5x5 acceptability matrix, RACI, verification and post-production planning
• Risk analysis & evaluation — hazard identification across 9 categories, P1-P5 / S1-S5 estimation, ALARP, benefit-risk triggers
• Risk control — priority hierarchy (inherent safety → protective measures → information for safety), verification methods, residual-risk evaluation
• Post-production monitoring — information sources, review triggers, RM-file update procedures, periodic review
• Extended domains — AI/ML risk (bias, drift, adversarial inputs), health-software cybersecurity, supply chain risk, cross-framework mapping

When to Use

• Implementing ISO 14971:2019 across the device lifecycle
• Building a hazard analysis / risk register using FMEA, FTA, HAZOP, or Use Error Analysis
• Evaluating residual risk and demonstrating ALARP or benefit-risk acceptability
• Extending risk management to AI/ML devices, cybersecurity, or supply chain
• Setting up post-production risk monitoring and Risk Management File update triggers