ISO 14971 Risk Management Audits for Medical Devices

Independent. Documented. Compliance-Focused.

ISO 14971 Internal Audits That Strengthen Risk and Regulatory Readiness

Wintersmith Advisory performs ISO 14971 internal audits that help medical device and IVD companies assess the completeness, accuracy, and traceability of their risk management systems—ensuring alignment with ISO 13485, MDR, IVDR, and FDA expectations.

Why choose Wintersmith Advisory for ISO 14971 audits?

• ISO 14971:2019-compliant audit methodology

• Evaluation of risk files, control measures, and traceability

• Verification of risk-benefit analysis and residual risk acceptability

• Integration with design history files (DHF), PMS, and CAPA

• Audit preparation for regulatory inspections and notified body review

• Actionable reporting and support for remediation

Risk Management Audits That Go Beyond the Checklist

A robust risk management process is central to medical device safety—and regulatory approval. Wintersmith Advisory delivers focused ISO 14971 internal audits to evaluate your system’s completeness, effectiveness, and alignment with regulatory expectations.

Comprehensive Evaluation Across Product and Quality Systems

We review your risk management procedures, sample risk files, traceability to design controls, and responsiveness to post-market feedback. Whether you're preparing for a certification audit, notified body inspection, or internal quality review, we provide documented findings and support to strengthen your system. Our approach helps you catch gaps before regulators do.

Audit Approach Built on Standards, Tailored to Regulation

• ISO 14971:2019 and ISO 19011 audit practices

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

• Regulatory alignment with EU MDR/IVDR, FDA, and MDSAP

• Objective reporting and support for nonconformance closure

Let’s Ensure Your Risk Management System Stands Up to Scrutiny

Ready to verify your risk management system?
Let’s conduct an audit that ensures ISO 14971 compliance and regulatory readiness.