ISO 14971 Risk Management System

Risk management is often treated as a document exercise, but auditors expect a living process that links hazards, risk controls, residual risk, and post-market feedback. This system gives you a practical ISO 14971 structure you can use to build and maintain a defendable risk-management file without reinventing the methodology. That means less time spent rebuilding documents from scratch and a stronger line of evidence when the process is sampled under audit.

What's included

• Risk Management Policy.docx
• Risk Management Plan Template.docx
• Risk Management Pre-Analysis Registers.xlsx
• Risk Evaluation and Control Workbook.xlsx
• Risk Benefit Analysis Worksheet.docx
• Overall Residual Risk Approval.docx
• Risk Management File Index and Traceability.xlsx
• PMS Data Sources and Signal Review.xlsx
• Risk Management Report Shell.docx

Best suited to: Medical device manufacturer, Quality manager, Regulatory consultant, and R&D team.

Useful in audit situations where you need to:

• Show a structured risk management process during ISO 13485 certification, surveillance, supplier, or internal audits.
• Support FDA inspections with controlled records, traceability, and process evidence related to risk management.
• Support EU MDR technical documentation or quality-system reviews where risk management records need to be complete, controlled, and consistent.

Use this system to move faster, create cleaner evidence, and reduce the time it takes to stand up or repair this part of your ISO 13485 framework.