Why ISO 14971 Matters
Every medical device manufacturer must demonstrate a systematic approach to identifying hazards, estimating risks, controlling risks, and monitoring effectiveness. ISO 14971 defines this process. Regulatory bodies (FDA, EU MDR, Health Canada) reference it as the foundational risk management standard. The Medical Device Safety Solution implements ISO 14971 not as a checklist, but as a live, traceable process embedded in the development workflow.Clause-by-Clause Coverage
Clause 4 — Risk Analysis
ISO 14971 requires identification of hazards, hazardous situations, and estimation of risk for each.| Requirement | Solution Feature | Evidence |
|---|---|---|
| Identify intended use and misuse | Use Step work items (24 scenarios) | useStep type with address links to user needs |
| Identify hazards | Hazard Catalog (68 entries, IEC 60601 taxonomy) | 4-level cascading hierarchy: Energy > Electrical/Mechanical/Thermal > subtypes |
| Identify hazardous situations | Risk Record hazardousSituation text field | Free-text description on each of the 55 risk records |
| Identify harms | Standard Harms catalog (25 entries with severity) | harm type with severity 1-5 (Negligible to Catastrophic) |
| Estimate risk | P1 x P2 probability model + harm severity | Two-factor probability (hazard occurrence x harm probability), bucketed and combined with severity in 5x5 matrix |
Clause 5 — Risk Evaluation
Risk evaluation compares estimated risk against acceptability criteria.| Requirement | Solution Feature | Evidence |
|---|---|---|
| Risk acceptability criteria | 5x5 risk matrix (probability x severity) | Three-level classification: Acceptable (green), Investigation (amber), Unacceptable (red) |
| Pre-mitigation risk level | preRisk field on risk records | Auto-computed from P x S lookup in the risk matrix |
| Automated risk matrix report | Risk Matrix Report (Velocity) | Pre-mitigation 5x5 distribution with color-coded cells |
Clause 6 — Risk Control
When risk is not acceptable, controls must be applied following the ISO 14971 priority order.| Requirement | Solution Feature | Evidence |
|---|---|---|
| Risk control hierarchy | riskControlType multi-enum | Three tiers: Inherent Safety by Design > Protective Measure > Information for Safety |
| Risk control measures | Risk Control work items (26 controls) | Stored in RiskControlPlan document, linked via mitigates role |
| Implementation traceability | implements link role | System/design requirements implement risk controls; test cases verify those requirements |
| Verification of effectiveness | Verification Evidence column in HARA risksheet | Two-hop traversal: Risk Control > Requirement > Test Case |
Clause 7 — Evaluation of Overall Residual Risk
Clause 7.1 — Residual Risk Evaluation
| Requirement | Solution Feature | Evidence |
|---|---|---|
| Post-mitigation risk assessment | postRisk field + post P1/P2 probabilities | Mirrors pre-mitigation structure with separate post-control probability fields |
| Residual risk classification | Post-mitigation risk matrix | Auto-computed from post-P x S lookup |
| Aggregate risk summary | Risk Matrix Report residual risk section | Conditional alert boxes: danger (unacceptable), warning (investigation), success (all acceptable) |
Clause 7.2 — Benefit-Risk Analysis
When residual risk remains unacceptable and no further controls are possible, a benefit-risk analysis determines whether the medical benefit justifies the risk.| Requirement | Solution Feature | Evidence |
|---|---|---|
| Benefit documentation | benefit text field on risk records | Free-text description of medical benefit |
| Benefit-risk determination | riskBenefitResult enum | Two values: benefitAcceptable, benefitNotAcceptable |
| Final risk classification | finalRisk computed field | Three-state decision tree: acceptable, unacceptable, benefitAcceptable |
| Additional controls assessment | additionalControlsPossible flag | Forces explicit evaluation before benefit-risk path |
Clause 7.3 — Overall Residual Risk
| Requirement | Solution Feature | Evidence |
|---|---|---|
| Aggregate residual risk review | Risk Matrix Report aggregate statistics | Count and percentage per risk level with conditional alerts |
Clause 7.4 — Risk Management Report
| Requirement | Solution Feature | Evidence |
|---|---|---|
| DHF-ready risk report | ISO 14971 HARA Report (Velocity) | Automated from live data with chapter numbering, all custom fields, print-ready CSS |
| Risk matrix documentation | Risk Matrix Report | Methodology documentation + two 5x5 matrices |
| DFMEA summary | DFMEA Summary Report | Per-subsystem failure mode statistics |
Clause 10 — Production and Post-Production
| Requirement | Solution Feature | Evidence |
|---|---|---|
| Process risk analysis | Process Step work items + PFMEA template | processStep type with inputs, outputs, equipment, verification fields |
| Process-to-component mapping | associates link role | ProcessStep links to SystemElement |
Annexes Coverage
| Annex | Topic | Solution Implementation |
|---|---|---|
| Annex C | Risk Management Plan | RiskControlPlan document (26 controls) with document workflow (draft > review > approved > published) |
| Annex D | Harm Severity | 5-level harm-severity enum: Negligible, Minor, Serious, Critical, Catastrophic |
| Annex E | Hazard Examples | HazardsCatalog (68 entries) with IEC 60601-aligned 4-level taxonomy |
| Annex F | Risk Estimation | P1 x P2 two-factor probability model with 5-level bucketing |
ALARP Principle
The three-level risk classification directly implements the ALARP (As Low As Reasonably Practicable) principle:- Acceptable: Risk is broadly acceptable. No further action required.
- Investigation (ALARP region): Risk must be reduced as far as reasonably practicable. Requires documented justification if controls cannot reduce risk further.
- Unacceptable: Risk must be reduced. Benefit-risk analysis is the only path to acceptance if controls are exhausted.
Related Concepts
- Dual Risk Methodology: HARA and DFMEA — How HARA and DFMEA complement each other
- Risk Matrix and P1xP2 Probability Model — Detailed probability bucketing and matrix mechanics
- Benefit-Risk Analysis (Clause 7.2) — Decision tree for unacceptable residual risks
- Risk Control Hierarchy — The three-tier control priority system