Dear Sir or Madam,
You have participated in our UDI EUDAMED Webinar 2021, so you are aware of the challenges medical device manufacturers face with the Medical Device Regulation of MDR2017/745 and IVDR 2017/746.
To ensure traceability, transparency and patient safety in a solution tailored to you we offer:
For SAP users: Our SAP UDI EU Add-On, which implements all EUDAMED requirements and represents an effective solution for the UDI EUDAMED implementation.
For non-SAP users: Our EUDAMED MDR/IVDR Excel spreadsheet, which serves as a template for collecting all UDI attributes and simplifying data entry and submission to EUDAMED.
In addition, we offer consulting services entirely based on your personal challenges.
Our range of services includes:
- EUDAMED updates
- UDI deadlines
- EUDAMED structure & applications
- UDI data requirements
- DI requirements & generation
- UDI business rules (MDR/IVDR)
- Legacy medical devices (MDD/ IVDD/ AIMDD)
- EUDAMED registration
- EUDAMED playground
- Data submission options
Are you looking for a comprehensive solution to the challenges in the UDI-EUDAMED environment, please do not hesitate to contact us for a customized demo.
If you want to get an overall view of our product again, feel free to watch our compact 2-minute summary of our SAP UDI EU Add-On.
If you are interested in a user-friendly software solution for corporate planning and reporting in the areas of controlling and finance, then we will be happy to recommend you the Allevo planning tool developed by our partner company, Kern AG. This integrates your planning data from Microsoft Excel reliably and automatically into SAP.
If you have any questions or comments, please do not hesitate to contact us.