ISO 14971 Risk Management System

Who This Kit Is For

Medical device and IVD manufacturers needing a full, integrated ISO 14971 risk management system that can stand alone or plug into an existing ISO 13485 QMS.

The Compliance Problem It Solves

• Disjointed risk activities across design, production and PMS with no single, coherent risk process.
• Incomplete risk management files, missing rationales, benefit-risk analyses and residual risk evaluations.
• Audits questioning the link between risk management, design controls, PMS and CAPA.

What You Get In This Kit

• Risk management SOP aligned with ISO 14971 requirements, including planning, analysis, evaluation, control and post-production monitoring.
• Risk management plan, report and risk file templates.
• Hazard analysis, risk evaluation and risk control forms and matrices.
• Linkage guidance to design control, PMS, vigilance and CAPA processes.

How This Kit Reduces Your Audit Risk

• Delivers a documented, traceable risk management process that maps directly to ISO 14971 clauses.
• Ensures risk activities are consistent, repeatable and linked to related QMS processes.
• Reduces gaps in risk documentation during audits, technical file reviews and submissions.

How To Implement It (Step-by-Step)

1. Download the system documents and align terminology with your QMS and product portfolio.
2. Define risk acceptability criteria and integrate the risk SOP with design, CAPA and PMS procedures.
3. Populate risk files for your devices using the provided templates and matrices.
4. Maintain and update risk files based on production and post-production information, as described in the SOP.

Technical & Regulatory Alignment

• Built for: ISO 14971:2019; tightly aligned with ISO 13485:2016 risk-based QMS requirements.
• Typical use: risk management for new products, changes, PMS updates and technical documentation.
• Document type: full risk management system (SOPs, templates and forms).