Unique Device Identification (UDI) Compliance Services

At Intertek, we understand the critical importance of Unique Device Identification (UDI) in the medical device industry. Our comprehensive UDI compliance services are designed to ensure that your medical devices meet all regulatory requirements, enhancing safety and traceability throughout their lifecycle.

What is Unique Device Identification (UDI)?

Unique Device Identification (UDI) is a system used by manufacturers to mark and identify medical devices within the healthcare supply chain. Implemented by the FDA and other global regulatory bodies, the UDI system facilitates easier tracking of devices, enhances the effectiveness of device recalls, and improves patient safety. Each Unique Device Identifier (UDI) is a unique numeric or alphanumeric code that includes device-specific information which is essential for compliance with global regulations.

Why is UDI Compliance Crucial?

• Enhanced Patient Safety: UDI helps in the precise identification of medical devices, leading to improved patient safety and reduced medical errors.
• Efficient Recall Management: With UDI, manufacturers and healthcare providers can quickly and effectively manage device recalls.
• Streamlined Regulatory Reporting: UDI simplifies the reporting process for adverse events and other regulatory obligations, making compliance more straightforward.

Unique Device Identification (UDI) On-demand Webinar

Unique Device Identifiers (UDI) are mandatory for medical devices and accessories in the U.S. and the EU. They can be found on the device and on packaging. Learn more with our 40-minute on-demand webinar.

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Intertek’s Unique Device Identifier (UDI) Compliance Services

Intertek offers end-to-end UDI compliance services tailored to your specific needs. Our experts assist with every step of the UDI compliance process, from initial consultation and planning through implementation and post-market surveillance.

• UDI Implementation Planning: We help you develop a strategic approach to UDI compliance, ensuring all your medical devices are properly labeled with a unique device identifier.
• UDI Data Management: Our services include support for data creation, management, and submission to global UDI databases such as the FDA’s Global Unique Device Identification Database (GUDID).
• Compliance Assurance: With extensive experience in regulatory compliance, Intertek ensures that your UDI implementation meets all regulatory requirements, avoiding costly delays and penalties.
• Training and Support: We offer comprehensive training and ongoing support to ensure your team is fully equipped to handle UDI compliance effectively.

Get Ahead with Intertek

Leverage Intertek’s expertise in Unique Device Identification to ensure your medical devices are compliant, traceable, and safe. Our tailored solutions help you navigate the complexities of UDI compliance with confidence. Contact us today to learn more about how we can assist you in achieving and maintaining UDI compliance.