risk-management-specialist

ISO 14971 risk management establishes a structured process to identify hazards, analyze risks, implement controls, and maintain documentation across your device's full lifecycle. This Skill guides you through risk management planning, hazard analysis, risk estimation, evaluation, control implementation, and residual risk assessment with integrated IEC 62304 support for software components.

A risk management file (RMF) documents all risk activities—planning, analysis, evaluation, controls, and post-production information—required by ISO 14971. This Skill provides structure for creating and maintaining your RMF with continuous improvement and CAPA integration to meet regulatory requirements.

ISO 14971 risk management extends to cybersecurity and data privacy considerations across hardware, software, and combination products. This Skill integrates these concerns throughout risk analysis, control selection, and post-production monitoring to address modern threat vectors in device development and deployment.

Yes. ISO 14971 requires post-production information handling and corrective/preventive action (CAPA) integration. This Skill covers establishing workflows to capture field data, evaluate emerging risks, implement controls, and document residual risk assessments after market release.

ISO 14971 applies to combination products, hardware, and software-only devices. This Skill integrates IEC 62304 software lifecycle requirements into risk management, ensuring unified hazard analysis, control verification, and risk-benefit evaluation across all device components.

Risk control implements measures to reduce identified risks to acceptable levels. Residual risk assessment verifies that remaining risks—after controls—stay within acceptable limits and that control benefits outweigh harms. This Skill structures both activities with verification and validation steps to meet ISO 14971 functional requirements.