Description:
This Risk Management Report documents our risk management review and overall benefit-risk conclusion for a medical device across the full lifecycle.

• Define controlled identifiers: Document Number, Revision, Approval, and Change History.

• Maintain Reference documents including EN ISO 14971:2019 and ISO/TR 24971.

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

• Confirm hazard logic using FMEA, Severity, Likelihood, and RPN.

• Re-estimate Residual risk and justify “undesirable” risks via B/R.

Your needs:

• Risk management report

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

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

Use this report when finalizing design changes, updating the risk management file, or preparing technical documentation to demonstrate that risk controls were applied and reviewed.

It summarizes critical outcomes. Residual risk is what remains after controls and matters for acceptability. AFAP means reducing risk as far as possible and matters for control justification.

• Document safety-related characteristics and traceability to hazards.

• Apply defined risk acceptability criteria and RPN thresholds.

• Verify risk control effectiveness using objective evidence.

• Confirm labeling/IFU safety information review where applicable.

• Confirm production and post-production monitoring inputs (PMS, complaints, vigilance, CAPA).

At Lexqara, we align your report with risk analysis, usability, clinical evaluation, PMS, and regulatory strategy. Resource Center [https://lexqara.com/resource-center] and Regulatory Strategy [https://lexqara.com/services/regulatory-strategy]. 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.

A well-maintained report supports Design History File consistency and speeds reviews during audits and submissions.