ISO 14971 Risk Management Implementation for Medical Devices

Structured. Compliant. Integrated with Your QMS.

ISO 14971 Implementation That Aligns Risk with Quality and Regulation

Wintersmith Advisory helps medical device and IVD companies implement ISO 14971:2019-compliant risk management systems that integrate seamlessly with ISO 13485 and regulatory expectations.

Why choose Wintersmith Advisory for ISO 14971 implementation?

• Full-lifecycle risk management framework setup

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

• Risk file structure, templates, and documentation support

• Alignment with design control, usability, and post-market feedback

• Training on hazard identification, risk estimation, and risk-benefit analysis

• Ready for audit and regulatory inspection

ISO 14971: The Foundation of Safe, Compliant Product Development

ISO 14971 is the international standard for risk management of medical devices and in vitro diagnostics—and a cornerstone of regulatory compliance. Wintersmith Advisory provides end-to-end implementation services for ISO 14971, helping you create a risk management process that’s aligned, documented, and embedded in your product lifecycle.

Integrated Risk Management Across the Entire Product Lifecycle

We support you in identifying hazards, evaluating risks, documenting control measures, and linking risk data to design and post-market surveillance. Whether you're building a standalone risk management process or integrating it with ISO 13485, EU MDR, or FDA QSR frameworks, we ensure your system supports both safety and compliance.

Standards-Aligned. Audit-Ready. Risk-Informed.

• ISO 14971:2019-aligned framework development

• Deep integration with ISO 13485, MDR, IVDR, and FDA QMS

• Structured risk files, FMEAs, and traceability support

• Risk-based thinking applied across product lifecycle

Let’s Build a Risk Management System That Delivers Confidence

Building or improving your risk management process?
Let’s implement a system that supports patient safety and regulatory confidence.