risk-management-specialist

Medical device hazard analysis for ISO 14971 involves identifying hazards, evaluating risks, and determining ALARP. This process uses dynamic risk matrices and FMEA/FTA templates to systematically document and control identified risks.

Calculating RPN and ALARP decisions requires applying a risk matrix calculator to evaluate hazard severity and occurrence. This establishes whether residual risks are acceptable or require further mitigation under ISO 14971 guidelines.

Post-production monitoring for medical device risks involves collecting PMCF data, updating the risk management file, and managing vigilance activities. This ensures ongoing ISO 14971 compliance by capturing real-world hazard evidence.

FMEA and FTA templates support medical device risk planning and control by structuring hazard analysis. They help define scope, responsibilities, and verification activities to systematically mitigate failures according to ISO 14971.

ISO 14971 risk management applies across the entire medical device lifecycle, covering risk planning, hazard analysis, evaluation, control, and post-production monitoring to ensure continuous safety and compliance.

A risk management file is needed for medical device hazard analysis to systematically document risk planning, evaluation, and control activities. It provides the traceability required to demonstrate ISO 14971 compliance.