Risk Management
The Risk Analysis section of P4SaMD is where you identify, assess, mitigate, and track risks for your medical device software in compliance with ISO 14971. Risks are managed natively inside the platform, so no external tool is required. Open it by clicking Risk Analysis in the left project sidebar.
Creating a Risk
Click + New Risk at the top of the risk list, then provide:
- Title: a concise description of the risk
- Hazard: the source of potential harm
- Harm: the damage that could result (e.g., patient injury, data loss)
- Harm category: one of Patient, Operator, Environment, or Device
- Initial severity: rated S1 (negligible) through S5 (catastrophic)
- Initial probability: rated P1 (improbable) through P5 (frequent)
Optionally, add the sequence of events (the causal chain from hazard to harm), the hazardous situation (the specific scenario in which harm could occur), and an assignee responsible for the risk.
On save, the risk appears in the list with an automatically assigned display ID (e.g., RSK-0001) and an Identified status.
ISO 14971 Risk Matrix
P4SaMD automatically computes the initial risk level based on the severity × probability combination using the ISO 14971:2019 "Option A" 5×5 risk matrix:
| Risk Level | Meaning |
|---|---|
| Unacceptable | Risk must be mitigated before the device can proceed |
| Tolerable | Risk is tolerable only if reduced as low as reasonably practicable |
| Acceptable | Risk is within acceptable limits |
This zone was previously labelled ALARP. As of P4SaMD v3.5.0, it is called Tolerable everywhere in the platform, and the matrix's severity/probability boundaries were realigned to the ISO 14971 "Option A" matrix. This was a genuine reclassification, not just a rename: some combinations that were previously Unacceptable are now Tolerable, including Severity 5/Probability 1, Severity 4/Probability 2, and Severity 3/Probability 3. See the v3.5.0 release notes for details. You can customize how the three zone names are displayed for your project from the Project Customization settings; this does not affect how risk levels are computed.
Risk Lifecycle
Each risk progresses through the following statuses:
Identified → Analyzed → Mitigation Required → Under Control → Verified
↓ ↓ ↓ ↓
Accepted Accepted Accepted Accepted
↓ ↓ ↓ ↓
Transferred Transferred Transferred Transferred
| Status | Description | Available Actions |
|---|---|---|
| Identified | Newly created risk, not yet fully analyzed | Analyze |
| Analyzed | Risk has been evaluated; risk level computed | Start Mitigation, Accept, Transfer |
| Mitigation Required | Risk requires control measures to reduce | Control (mark mitigated), Accept, Transfer |
| Under Control | Control measures are in place | Verify, Accept, Transfer |
| Verified | All control measures verified effective | Accept |
| Accepted | Risk formally accepted with documented rationale | None (terminal) |
| Transferred | Risk responsibility transferred with rationale | None (terminal) |
| Deprecated | Risk no longer applicable | None (terminal) |
Accepting or transferring a risk requires a mandatory rationale explaining the decision. Verifying a risk requires all linked control measures to be verified first.
Control Measures
Control measures are the mitigations you put in place to reduce a risk. Add them to any risk from the risk detail view. Mark each control measure as verified once its effectiveness is confirmed.
After control measures are applied, you can record residual severity and residual probability values on the risk to document the reduced risk level.
Risk List and Filtering
The risk list shows all risks in the active workspace version. The summary columns are display ID, hazard, harm, severity, probability, risk level, residual risk level, status, and assignee.
Summary cards at the top show:
- Total risks in the version
- Unacceptable risk count
- Tolerable risk count
- Under Control risk count
Filters
Filter the risk list by:
- Harm category (Patient, Operator, Environment, Device)
- Severity level (S1 to S5)
- Probability level (P1 to P5)
- Initial risk level (Unacceptable, Tolerable, Acceptable)
- Residual risk level
- Status
- Assignee
Search and Sort
Use the search bar to find risks by title or display ID. Sort by sequence number, last updated date, severity, probability, or risk level.
Traceability
From the risk detail view, you can see and manage links to:
- Requirements: which requirements this risk relates to
- Test cases: verification evidence for control measures
- History: a full audit trail of every change, transition, and rationale
Import and Export
Import risks from a CSV file for bulk onboarding. Export the current risk register, with active filters applied, for external reports or regulatory submissions.
Deprecating a Risk
If a risk is no longer applicable (e.g., the related feature was removed), use the Deprecate action from the risk detail view. A rationale is mandatory. Deprecated risks remain in the system for audit traceability but are excluded from active risk counts.