Our Guide to Find the Best Fit
You would like to book the mytracekey UDI Manager but are unsure which package best suits your needs? We are happy to help you find the right package. Therefore, we have detailed and compared the individual packages below to make your decision easier.
mytracekey UDI Manager BASIC
Our entry-level package allows you to easily capture, manage, and report your UDI data to EUDAMED. Perfect for small businesses with a low volume of UDIs who still want the convenience and security of a centralized master data management solution.
BASIC Features
- Data Volume: 10 UDIs are included in the BASIC version; after that, the pay-per-use model applies. This makes the BASIC version ideal for small UDI volumes.
- Data Management: Manage your UDI data, including all templates (MDR, MDD, IVDR, IVDD, AIMDD).
- Data Import: Import your UDI data as an Excel file.
- Data Validation: Check your UDI data for completeness (EUDAMED Business Rules Check).
- Data Transfer: Data transmission to EUDAMED (XML bulk upload).
- Onboarding: Comprehensive documentation package including training materials.
- Requirements: No IT infrastructure or prior knowledge required.
Pricing
- Contract Duration: Monthly contract term
- Base Fee: €39/month
- Additional Fees: €1.20/UDI for each additional UDI per month
mytracekey UDI Manager FULL
You are a “frequent user” and therefore want more comfort and efficiency in your UDI management. Then the mytracekey UDI Manager FULL is just right for you.
With the mytracekey UDI Manager FULL, we provide you with numerous functions that you need to easily capture, manage, and report your UDI data to EUDAMED. Additionally, you get everything you need to make your quality and UDI management even more efficient and fully compliant.
FULL Features
- Data Volume: 100 UDIs are included in the FULL version; after that, the pay-per-use model applies. This makes the FULL version ideal for larger UDI volumes.
- Data Management: Manage your UDI data, including all templates (MDR, MDD, IVDR, IVDD).
- Data Import: Import your UDI data as an Excel file.
- Data Validation: Check your UDI data for completeness (EUDAMED Business Rules Check).
- Data Transfer: Data transmission to EUDAMED (XML bulk upload). The M2M function (direct connection to EUDAMED) can be additionally booked in this package.
- Onboarding: Comprehensive documentation package, including training materials.
- Requirements: No IT infrastructure or prior knowledge required.
- Data Overview: The Task Manager keeps track of your tasks and informs you which UDIs still need to be reported.
- Compliance Package: Audit trail and validation documentation, as well as access to the test system, support you in implementing legal requirements for quality assurance and IT security.
Pricing
- Contract Duration: Monthly contract term
- Base Fee: €79/month
- Additional Fees: €0.04/UDI for each additional UDI per month
Add-On: M2M – The Direct Wire to EUDAMED
If you need even more advanced UDI management, consider adding the M2M function. This interface between EUDAMED and the mytracekey UDI Manager provides maximum convenience, enabling you to manage all your UDI tasks within the mytracekey software.
The M2M (Machine-to-Machine) interface directly connects mytracekey with EUDAMED. This direct link enhances quality management by securely transmitting data and automatically creating a comprehensive audit trail with version control. It also allows for faster reporting of large UDI volumes to EUDAMED.
M2M Features
- Data Transfer: With the direct connection to EUDAMED, you can exchange data with EUDAMED at any time without limits.
- Compliance: All data transmissions to EUDAMED are visible in the UDI Manager. Ideal for providing proof of data transmission to EUDAMED (e.g., during audits or upon request from authorities).
- Requirements: Active mytracekey UDI Manager FULL subscription.
Pricing
- Contract Duration: Monthly contract term
- Base Fee: €50/month
- Additional Fees: None