Maintain Your ISO 14971 Risk Management System with Confidence

Keep Risk Files Current. Ensure Traceability. Support Compliance.

Ongoing ISO 14971 Maintenance for Active, Compliant Risk Management

Wintersmith Advisory provides structured ISO 14971 maintenance services to help medical device organizations keep risk management processes active, aligned, and inspection-ready—across design, manufacturing, and post-market phases.

Why work with Wintersmith Advisory to maintain ISO 14971 compliance?

• Periodic risk file reviews and updates

• Linkage with design changes, complaints, and post-market feedback

• Risk control revalidation and traceability checks

• Integration with ISO 13485, EU MDR, IVDR, and FDA requirements

• CAPA alignment and continuous improvement

• Audit and inspection readiness support

Risk Management Doesn’t End at Design Transfer

Risk management isn’t static—especially in regulated medical device environments. ISO 14971 requires ongoing risk evaluation and control across the entire product lifecycle. Wintersmith Advisory provides proactive maintenance services to ensure your risk management system remains compliant, traceable, and responsive to change.

Proactive Risk File Maintenance Across the Product Lifecycle

We help you update risk analyses based on complaints, design changes, and post-market data. We verify control effectiveness, ensure documentation reflects current risk status, and support ongoing alignment with ISO 13485 and regulatory expectations. Whether you’re preparing for an MDSAP audit or responding to a notified body, we help ensure your risk files hold up to scrutiny.

Compliance That Connects Risk, Quality, and Regulation

• ISO 14971:2019 lifecycle-aligned risk management

• Traceability and documentation control expertise

• Integrated support with ISO 13485, CAPA, and PMS systems

• Regulatory readiness for MDSAP, MDR, IVDR, and FDA inspections

Let’s Keep Your Risk Files Ready for Review

When was your last risk file review?
Let’s build a maintenance plan that keeps your ISO 14971 system accurate and audit-ready.