Description:
This Risk Management Report documents the risk management review and conclusion that residual risks are acceptable when weighed against clinical benefits, using a lifecycle approach aligned to EN ISO 14971:2019.

• List and maintain Reference documents (e.g., Risk Analysis, Risk Management Plan, Usability Engineering File, Clinical Evaluation Procedure, EN ISO 14971:2019).

• Define Scope of the risk assessment consistent with the Risk Management Plan.

• Document Identification of safety-related characteristics using ISO/TR 24971 Annex A questions and data inputs.

• Record Hazards, Hazardous situations, Harms, lifecycle phases, and traceability to sources in the Risk Analysis.

• Apply FMEA and Risk Priority Number (RPN) ranking with acceptability criteria defined in the plan.

• Document Risk control implementation AFAP, plus verification of effectiveness (testing, V&V, process validation, clinical data).

• Provide Benefit-Risk (B/R) justification for “undesirable” residual risks and conclude on overall residual risk acceptability, including production and post-production data inputs (PMS, complaints, vigilance, CAPA).

Your needs:

• Risk management report

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

• Reduce rework, strengthen clinical benefit-risk defensibility, and improve audit readiness.

Use this report during design transfer, major changes, and periodic risk reviews to evidence that the risk management plan was implemented and that residual risk remains acceptable across the device lifecycle.

It summarizes key outcomes from the risk management file. Residual risk is the risk remaining after controls; it matters because it must be acceptable versus benefits. AFAP means reducing risk as far as possible; it matters because it drives justified, evidence-based controls.

• Confirm plan implementation and defined responsibilities.

• Demonstrate complete hazard/hazardous situation identification with traceability.

• Apply documented risk acceptability criteria and RPN methodology.

• Implement and verify risk control measures with objective evidence.

• Re-estimate and evaluate individual residual risks post-controls.

• Justify benefit-risk for undesirable residual risks (grouped rationale).

• Evaluate overall benefit-risk via expert and/or labeling review where applicable.

• Define production/post-production feedback loops into the risk management file.

At Lexqara, we align your risk management report with your risk analysis, usability, clinical evaluation, PMS inputs, and technical documentation—supporting regulatory strategy, design support, and audit/inspection readiness without over-claiming outcomes. Resource Center [https://lexqara.com/resource-center] and Regulatory Strategy [https://lexqara.com/services/regulatory-strategy]. See EU MDR (Regulation (EU) 2017/745) [https://eur-lex.europa.eu/eli/reg/2017/745/oj]. Download the template or request a short gap assessment.