> iso_14971:2019
ISO 14971:2019
Medical Devices — Application of Risk Management to Medical Devices
ISO 14971:2019 specifies a systematic process for identifying medical device hazards, estimating and evaluating associated risks, controlling these risks, and monitoring the effectiveness of controls across the entire product lifecycle. It enforces a strict hierarchy of risk controls: inherent safety by design, protective measures, and safety information.
Scope & Applicability
Applies to all stages of the life-cycle of a medical device, from initial concept through design, manufacturing, post-market surveillance, and decommissioning.
Non-Coverage Boundaries
Does not establish acceptable risk levels or clinical decision thresholds, which must be justified by clinical data and manufacturer policy.
Key Clauses & Control Requirements
Risk Analysis
Systematic identification of hazards, hazardous situations, and foreseeable sequences of events that can lead to harm.
Risk Control Hierarchy
Mandatory prioritization: (1) inherently safe design, (2) protective measures in device or manufacturing, (3) information for safety / user training.
Required Regulatory & Audit Evidence Artifacts
- [✓]Risk Management Plan (RMP) approved by clinical and technical leadership
- [✓]Hazard Analysis and Failure Mode and Effects Analysis (FMEA / PHA)
- [✓]Risk Management File (RMF) linking hazards to mitigation test results
“Residual risk cannot be mitigated by wishful thinking or user manual disclaimers. In software engineering, architectural isolation and deterministic validation are the only credible risk controls.”
Cross-Surface Ecosystem Relationships
- ISO 14971:2019 Medical devices — Application of risk management ↗(International Organization for Standardization)
Frequently Asked Questions
Can an economic cost-benefit analysis be used to justify accepting a patient safety risk under ISO 14971?
No. ISO 14971 explicitly forbids using economic considerations as a justification for accepting a safety hazard to patients or users.