Strengthening Device Traceability and Regulatory Compliance
The Unique Device Identification (UDI) system plays a vital role in enhancing the traceability, safety, and post-market surveillance of medical devices. By assigning standardized identifiers, the UDI framework helps reduce medical errors and supports regulatory oversight. Medral Global provides end-to-end support for UDI listing, ensuring that your medical devices are fully compliant and prepared for successful market entry.
Our UDI Listing Services
Strategic Planning and Regulatory Alignment
- Regulatory Guidance: We offer clear, up-to-date guidance on UDI regulations from key authorities such as the FDA and the European Commission.
- Implementation Strategy: Our team develops a customized UDI rollout plan aligned with your device categories and regulatory priorities.
UDI Code Generation and Labelling Support
- UDI Creation: We assist with generating UDI codes using accredited agencies like GS1, HIBCC, or ICCBBA to meet jurisdictional requirements.
- Label Integration: Our experts ensure that UDI codes are properly incorporated into your device labeling and packaging in accordance with visibility, durability, and scanning standards.
Database Submission and Regulatory Coordination
- GUDID Entry: We handle the submission of your UDI data to the FDA’s Global Unique Device Identification Database (GUDID), ensuring accuracy and completeness.
- EUDAMED Support: For the EU market, we assist in the structured submission of device identifiers to EUDAMED, ensuring full MDR compliance.
System Integration and Training
- Quality System Alignment: We help integrate UDI procedures with your existing quality management system, ensuring ISO 13485 compliance.
- Team Training: Our training programs equip your internal teams with the knowledge and tools needed for ongoing UDI management.
Ongoing Monitoring and Data Management
- Surveillance Framework: We support the development of processes for tracking UDI data related to device performance, recalls, or field safety notices.
- UDI Maintenance: Our team manages updates and revisions to UDI entries based on product changes or regulatory updates.
Why Choose Medral Global for UDI Listing?
- Expert Knowledge: We bring deep expertise in global UDI regulations and compliance frameworks, covering both U.S. and EU requirements.
- Customized Approach: Each solution is tailored to your device specifications, market strategy, and business operations.
- End-to-End Service: From initial planning to submission and post-market updates, we provide complete UDI support.
- Commitment to Quality: Our focus on accuracy and compliance ensures your devices meet global standards and are ready for market success.
Achieve UDI Compliance with Medral Global
Simplify your UDI implementation and reinforce product traceability with expert guidance from Medral Global. Get in touch with us today to ensure your devices meet all regulatory requirements and are fully prepared for global distribution.