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StandardsQuality System
ISO 14971
International standard for the application of risk management to medical devices.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026
Definition
ISO 14971:2019 specifies terminology, principles, and a process for risk management of medical devices, including software and in-vitro diagnostics, throughout the device lifecycle.What this means in practice
Risk management per ISO 14971 underpins design controls, cybersecurity risk decisions, post-market surveillance, and benefit-risk determinations expected by FDA, EU notified bodies, and other regulators.Use cases
1 scenario1
Risk file for an AI-enabled radiology triage tool
Risk Management leadThe team builds a risk management file: hazard analysis covering false negatives, automation bias, and model drift; risk controls including human-in-the-loop review and performance monitoring; and a benefit-risk conclusion tied to clinical evidence.
OutcomeThe file supports both FDA and EU MDR submissions and drives the post-market performance monitoring plan.
Cross-references
Uses
Concepts or artefacts this term builds on.
Used by
Things that build on this term.
Overlaps with
Covers some of the same ground; not interchangeable.
See also
Closely related context worth reading.
Primary references
3 sourcesLink health: 3 verified· last checked 2026-05-09
ISO·2IEC·1
- 1
ISO 14971:2019VerifiedISOiso.org
- 2
ISO Standards Catalogue - HealthVerifiedISOiso.org
- 3
IEC Webstore - Medical EquipmentVerifiedIECwebstore.iec.ch
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