Workflow Guides
Follow these guides in order for a complete HARA analysis, or jump to a specific step:- Identify Hazards and Harm Scenarios Link hazards from the IEC 60601 hazard catalog, associate harms from the standard harms catalog, and describe the hazardous situation for each use step. This establishes the risk record’s hazard chain: Use Step —> Hazard —> Hazardous Situation —> Harm.
- Evaluate Initial Risk (Pre-Mitigation) Score P1 (hazard probability) and P2 (harm probability) for each risk record. The risksheet calculates the composite probability and determines the pre-mitigation risk level using the 5x5 risk matrix.
- Assign Risk Controls to Hazards Link risk controls from the Risk Control Plan to risk records. Controls follow the ISO 14971 hierarchy: inherent safety by design, then protective measures, then information for safety.
- Evaluate Residual Risk (Post-Mitigation) After assigning controls, re-score P1 and P2 to reflect the reduced probabilities. Determine whether residual risk is Acceptable, requires Investigation, or remains Unacceptable.
- Perform Benefit-Risk Analysis For risk records where post-mitigation risk is in the Investigation zone, document the clinical benefit and evaluate whether benefits outweigh residual risks per ISO 14971 clause 7.4.
- Use Hazard and Harm Catalogs Browse the reusable Hazards Catalog (68 entries with IEC 60601 taxonomy) and Standard Harms catalog (25 entries with severity levels). Learn how to search, filter, and link catalog entries to risk records.
Prerequisites
Before starting HARA analysis, ensure:- The project has been installed with all risk templates
- System elements have been defined (the product decomposition)
- A HARA document has been created from the HARATemplate
- You have access to the Nextedy risksheet editor
Key Concepts
Understanding these concepts will help you work through the HARA guides effectively:| Concept | Page |
|---|---|
| The P1xP2 probability model | Risk Matrix and P1xP2 Probability Model |
| IEC 60601 hazard taxonomy | IEC 60601 Hazard Taxonomy |
| Risk control priority order | ISO 14971 Risk Control Hierarchy |
| When benefit-risk analysis is needed | Benefit-Risk Analysis (Clause 7.2) |
After HARA
Once all risk records have been evaluated and controls assigned:- Generate the ISO 14971 HARA Report for regulatory submission
- Read the Risk Matrix Report for an overview of risk distribution
- Review and Approve the Risk Document for formal sign-off