Description:
This Risk Analysis Report supports structured FMEA-based risk analysis by documenting hazards, estimating risk, defining controls, and confirming residual risk acceptability across the device lifecycle.

• Identify Hazards, Hazardous situations, and related Harms with traceable sources.

• Define the sequence of events and operating condition (normal or fault) for each scenario.

• Rate Severity and Likelihood to calculate Risk Priority Number (RPN).

• Classify risk acceptability (e.g., acceptable/undesirable/intolerable) per the defined criteria.

• Document Risk control measures implemented AFAP and link objective evidence.

• Record Verification of effectiveness (test/V&V/validation/clinical data) for controls.

• Re-estimate Residual risk after controls and confirm acceptability.

Your needs:

• Risk analysis report

• Risk analysis report for ISO 14971, ISO 13485 and MDR compliance

• Reduce rework, strengthen traceability, and improve audit readiness.

This spreadsheet is used when performing and updating the device risk analysis to keep risk decisions consistent, reviewable, and evidence-based.

It captures core risk logic. A Hazardous situation is the circumstance where people are exposed to a hazard; it matters because it anchors harms and controls. RPN combines severity and likelihood; it matters because it supports consistent prioritization.

• Document hazard-to-harm traceability for each scenario.

• Apply defined severity/likelihood scales and calculate RPN.

• Record initial risk evaluation and acceptability decision.

• Define risk controls and link supporting evidence.

• Verify control effectiveness and record results.

• Recalculate residual risk and confirm acceptability.

At Lexqara, we align your risk analysis with your risk management plan, design outputs, verification evidence, and technical documentation—supporting regulatory strategy, design support, and audit readiness. Resource Center [https://lexqara.com/resource-center] and Regulatory Strategy [https://lexqara.com/services/regulatory-strategy]. ISO 14971 [https://www.iso.org/standard/72704.html]. Download the template or request a short gap assessment.