Medical Device Unique Device Identification (UDI) Listing

Enhancing Traceability and Compliance

The Unique Device Identification (UDI) system is a regulatory requirement designed to improve the traceability and safety of medical devices. By providing a standardised identification for each device, UDI enhances post-market surveillance and reduces medical errors. IQzyme offers comprehensive support for the UDI listing process, ensuring your medical devices meet regulatory requirements and are positioned for successful market access.

Our UDI Listing Services

UDI Strategy and Planning

Regulatory Guidance: Provide detailed guidance on UDI requirements as mandated by regulatory authorities such as the USFDA and the European Commission.

Implementation Strategy: Develop a tailored UDI implementation strategy that aligns with your product portfolio and regulatory objectives.

UDI Generation and Assignment

UDI Creation: Assist in the creation of UDI codes, ensuring compliance with GS1, HIBCC, or other accredited issuing agencies.

Labelling Requirements: Guide the incorporation of UDI codes into device labelling and packaging, adhering to regulatory standards for visibility and readability.

Data Submission and Management

GUDID Submission: Prepare and submit the Global Unique Device Identification Database (GUDID) entries for FDA-regulated devices, ensuring accurate and complete data representation.

EUDAMED Compliance: Assist with data submission to the European Database on Medical Devices (EUDAMED) for devices marketed in the EU.

Quality Systems Integration

Process Alignment: Align UDI processes with your existing quality management systems, ensuring seamless integration and compliance with ISO 13485 standards.

Training and Support: Provide training for your team on UDI processes and requirements, ensuring ongoing compliance and efficiency.

Post-Market Surveillance and Updates

Monitoring and Reporting: Develop a framework for monitoring UDI-related activities, including tracking device recalls and field safety notices.

Data Updates: Manage updates to UDI data as required by regulatory changes or product modifications.

Why Choose IQzyme for UDI Listing?

Regulatory Expertise: Our team has extensive experience navigating UDI requirements across multiple jurisdictions, ensuring your devices comply with global standards.

Customized Solutions: We offer tailored UDI services that meet your specific product and market needs, enhancing traceability and compliance.

Comprehensive Support: From strategy development to data submission, we provide end-to-end support to streamline your UDI implementation.

Commitment to Excellence: We are dedicated to enhancing the safety and traceability of your medical devices, ensuring regulatory success and market access.

Achieve UDI Compliance with IQzyme

Streamline your UDI listing process and enhance device traceability with IQzyme’s expert guidance and support. Contact us today to learn how we can assist you in meeting UDI requirements and ensuring compliance in global markets.