Expertise.
UDI Management & EUDAMED.
Fully comply with your UDI and EUDAMED obligations - for MDR and IVDR-compliant medical devices and in-vitro diagnostics.
Compliant?
Are your UDI data complete and structured in accordance with MDR or IVDR
Reliable?
Are your EUDAMED entries correctly maintained and can they be audited at any time?
Efficient?
Already use automated processes for UDI creation and maintenance
Structured UDI and EUDAMED strategies for manufacturers and suppliers.
UDI and EUDAMED requirements are technically demanding and regulatory precise - we help you to combine both levels securely.
The introduction of the UDI obligation under MDR and IVDR brings new requirements for product labeling, data maintenance and data transmission. Manufacturers must label products correctly with UDI-DI and UDI-PI, maintain systems and provide EUDAMED-compliant information.
We help you to set up your UDI strategy - from the initial classification and technical mapping to regular maintenance. We structure your data models, define unique UDI fields, guide you through the registration process in EUDAMED and help with queries or deviations in the course of audits or requests from authorities.
Whether individual systems or product families - we create clarity, take care of validation and ensure audit-proof implementation.
Maintain an overview of your UDI obligations - we support you with structure, submission and compliance.
UDI & EUDAMED - Our services at a glance.
Our service portfolio covers all the building blocks of successful UDI management - from data structure to system integration.
UDI strategy and data structure.
- Development of a UDI system according to MDR and IVDR
- Definition of UDI-DI, PI, Basic UDI and product family logic
- Creation of structured templates for labeling & data export
EUDAMED registration and care.
- Support with initial registration in EUDAMED
- Data mapping, upload and validation
- Review of existing entries and troubleshooting
Integration into your processes.
- Connection of ERP/PLM systems to UDI workflows
- Label generation, serial number assignment and system validation
- Training and SOPs for audit-proof maintenance
Case studies - UDI obligations implemented correctly.
Our project examples show how companies of all sizes have successfully implemented their UDI and EUDAMED obligations.
UDI implementation for an international MedTech portfolio
Error analysis and correction of EUDAMED entries
Automation of UDI creation in an ERP system
Challenge.
A manufacturer with over 500 SKUs needed a UDI strategy for the MDR transition.Measures.
- Analysis of all product families and assignment to UDI-DI groups
- Definition of the structure for EUDAMED and labeling processes
- Validation of existing data fields and data transfer
Results.
- Complete system structure prepared for EUDAMED
- Audit-proof assignment for all SKUs
- Audit-capable UDI database with workflow connection
Success.
Clearly defined UDI logic for product families and international market approval.Make your UDI system MDR and IVDR compliant - with a clear plan for structure, data maintenance and submission.
Structure, security and traceability for your product labeling.
Our solutions help you to implement UDI and EUDAMED in a legally compliant, efficient and structured manner.
We structure your UDI data in accordance with MDR and IVDR, create logical product relationships and ensure complete labeling.
We take care of registration, validation and maintenance of your entries - even in the event of changes, audits or queries.
We integrate UDI processes into your system landscape and make your labeling audit-proof and traceable at all times.
Rely on a reliable UDI and EUDAMED system.
Related topics - For complete compliance.
These topics supplement your UDI strategy with regulatory and quality-related aspects.