ISO 14971 — Risk Management
Plain-language guides to ISO 14971:2019 — the international risk management standard for medical devices.
ISO 14971:2019 — ISO ↗Free ISO 14971 Risk Matrix Tool
Estimate initial and residual risk in minutes — with required actions and mandatory document checklist.
What is ISO 14971 and who must comply?
Scope, applicability, and regulatory context of the risk management standard.
How to identify hazards and hazardous situations
Systematic hazard identification methods: FMEA, FTA, and hazard checklists.
How to estimate and evaluate risk
Probability, severity, and risk acceptability criteria under ISO 14971:2019.
How to implement risk controls
The three-tier hierarchy: inherent safety, protective measures, information for safety.
What is residual risk and overall residual risk?
After controls: evaluating and documenting remaining risk acceptability.
How does ISO 14971 relate to MDR and IEC 62304?
Integration points with EU MDR Annex I, GSPR 8, and software risk management.
What does an auditor check for ISO 14971?
Audit findings, common gaps, and RMF documentation auditors focus on.
ISO 14971 third edition: what changed in 2019?
Key differences between ISO 14971:2012 and ISO 14971:2019 that affect your RMF.