Risk Management

The Risk Analysis section of P4SaMD enables you to identify, assess, mitigate, and track risks associated with your medical device software in compliance with ISO 14971. Risks are managed natively inside the platform — no external tool is required. Open it by clicking Risk Analysis in the left project sidebar.

Creating a Risk

To add a new risk, click + New Risk at the top of the risk list. You will be prompted to 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)

You can also optionally provide the sequence of events (the causal chain leading from hazard to harm), the hazardous situation (the specific scenario in which harm could occur), and an assignee responsible for managing this risk.

After saving, 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

Terminology update in v3.5.0

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 — for example, Severity 5/Probability 1, Severity 4/Probability 2, and Severity 3/Probability 3 — are now Tolerable. 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	— (terminal)
Transferred	Risk responsibility transferred with rationale	— (terminal)
Deprecated	Risk no longer applicable	— (terminal)

Accepting or transferring a risk requires a mandatory rationale explaining the decision. Verifying a risk requires that all linked control measures have been verified first.

Control Measures

Control measures are the mitigations you put in place to reduce a risk. You can add control measures to any risk from the risk detail view. Each control measure can be marked as verified once its effectiveness has been 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 displays all risks in the active workspace version with summary columns showing the display ID, hazard, harm, severity, probability, risk level, residual risk level, status, and assignee.

Summary cards at the top provide an at-a-glance view:

• Total risks in the version
• Unacceptable risk count
• Tolerable risk count
• Under Control risk count

Filters

You can filter the risk list by:

• Harm category (Patient, Operator, Environment, Device)
• Severity level (S1–S5)
• Probability level (P1–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. Sorting is available 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

You can import risks from a CSV file for bulk onboarding and export the current risk register (with active filters applied) for use in 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 mandatory rationale is required. Deprecated risks remain in the system for audit traceability but are excluded from active risk counts.