CROSSWALK
ISO 14971 Risk Management Crosswalk
Clause-by-clause breakdown of ISO 14971 risk management requirements. See how each step maps to ISO 13485, FDA QMSR, and what the scanner evaluates.
Risk Management
| ISO 14971 Clause | ISO 13485 Mapping | Requirement | Gaps | Details |
|---|---|---|---|---|
| §4.1 | 7.1 | Risk Management Process | 3 | View → |
| §4.4 | 7.1 | Risk Management Plan | 2 | View → |
| §5.2 | 7.3.3 | Intended Use and Reasonably Foreseeable Misuse | 1 | View → |
| §5.4 | 7.1 | Hazard Identification and Risk Estimation | 2 | View → |
| §6 | 7.1 | Risk Evaluation Against Acceptability Criteria | 1 | View → |
| §7.1 | 7.3.3 | Risk Control Option Analysis | 2 | View → |
| §7.3 | 7.1 | Residual Risk Evaluation and Benefit-Risk Analysis | 2 | View → |
| §8 | 5.6 | Overall Residual Risk Evaluation and Risk Management Review | 1 | View → |
| §10 | 8.2.1 | Production and Post-Production Information Review | 2 | View → |
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