The final rule for Unique Device Identification (UDI) has been passed. Medical device manufacturers are obligated to comply with industry-altering regulations — and the time to begin is now. QPharma’s seasoned medical device subject matter experts have been closely monitoring the evolving requirements for UDI compliance, and our consultants are at the ready to help companies achieve total compliance.
The medical device affiliate of QPharma, understands that value-chain partners frequently have differing requirements and capabilities for UDI labeling standards. Our team collaborates with clients and their suppliers to design an approach to UDI labeling that will satisfy all stakeholder requirements. Regardless of the size of your UDI project — whether you need additional expert resources, or a complete team headed by an experienced project manager — our affilite has developed systems and product methodologies to quantify project costs; identify the appropriate product labeling standards; integrate UDI requirements with Master Data Management programs; validate systems, facilities, equipment, and processes; and ensure that our clients apply the right UDI-compliant label, to the right product, at the right time during manufacture.
- Accurate UDI product/project cost estimation using our proprietary systems
- Guidance on the best labeling standard (GS1, HIBCC, ISBT 128) for each organization
- Comprehensive present “as-is” UDI readiness assessment
- Deep analysis to identify and address gaps in UDI readiness
- Collaborative project planning
UDI Project Execution
- Guidance on needed size and scope of effort
- Clear and cost-effective design of future “to-be” UDI project plans
- Focus of project effort into specific tracks with defined deliverables
- Work Breakdown Structure to drive project threads
- Responsibility Matrices to keep each resource focused on deliverables
- Flexible approach to ensure that issues, risks, and assumptions are managed
- Comprehensive validation solutions
- Driving focus on UDI readiness within agreed budget
To learn more about QPharma’s UDI compliance solutions for device companies, please contact us.