Achieve Regulatory Compliance with Accurate UDI Data Elements
Seamless UDI Compliance for Global Regulations
Ensuring accurate and compliant Unique Device Identification (UDI)
Our expert-driven approach simplifies UDI implementation, helping you navigate FDA and EU MDR requirements with confidence.
Save time, money, and hassles
Seamless Label Integration
Regulatory Compliance Assurance
How does this work?
UDI Data Definition
We define and structure UDI elements as per FDA and EU MDR requirements.
Labeling & Direct Marking
Integration of UDI into labels and direct marking for traceability.
Database & Submission
Preparing and submitting data to EUDAMED and GUDID for compliance.
Comprehensive Definition and Setup of UDI Data Elements
Accurate definition and setup of Unique Device Identification (UDI) data elements are essential for regulatory compliance.
We provide expert guidance on UDI requirements, ensuring your devices meet all regulatory standards.
Standards:
- FDA UDI Rule
- EU MDR UDI requirements
Services:
- UDI data element definition
- Database setup
- Compliance checks
Compliance Roadmap Tailored to Device-Specific Requirements
Creating a compliance roadmap tailored to your medical device’s unique requirements is crucial for regulatory success.
Our customized roadmaps outline essential steps and milestones for achieving regulatory approval.
Our approach ensures a clear, actionable path to compliance, helping you avoid delays and meet all regulatory expectations.
Services:
- Initial Gap Assessment
- Compliance Strategy Development
- Ongoing Regulatory Updates
Seamless Integration of UDI within Labeling Systems
Integrating UDI within your labeling systems is crucial for regulatory compliance and product traceability.
We offer support in integrating UDI into your labeling processes, ensuring seamless operations and compliance.
Services:
- Labeling system review
- UDI integration planning
- Implementation support
Expert Support for EUDAMED Registration and Data Submission
Registering and submitting data to the European Database on Medical Devices (EUDAMED) is mandatory under the EU MDR.
We provide comprehensive support for EUDAMED registration and data submission, ensuring timely and accurate compliance.
Regulations:
- EU MDR
- In Vitro Diagnostic Regulation (IVDR)
Services:
- EUDAMED registration
- Data submission preparation
- Compliance monitoring
Achieve Compliance and Submit Data to GUDID
Ensuring compliance and submitting data to the FDA's Global Unique Device Identification Database (GUDID) is essential for regulatory compliance.
We offer support for GUDID submissions, ensuring your devices meet all regulatory requirements.
Regulations:
- FDA
- UDI Rule
Services:
- GUDID data preparation
- Submission support
- Compliance checks
Effective Implementation of Direct Marking Requirements
Implementing direct marking requirements is crucial for regulatory compliance and product identification.
We provide support for the implementation of direct marking techniques, ensuring your products meet all regulatory standards.
Regulations:
- FDA UDI Rule
- EU MDR UDI requirements
Services
- Direct marking strategy development
- Technique implementation
- Compliance verification
Advanced Laser Marking and Direct Marking Techniques
Utilizing laser marking and other direct marking techniques is essential for durable and compliant product identification.
We offer expertise in implementing advanced marking techniques to enhance product traceability and compliance.
Services:
- Laser marking implementation
- Other direct marking techniques
- Quality and compliance checks
Reach out to us and achieve Regulatory Compliance with Accurate UDI Data Elements
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