With the FULL package, you get a tool that provides convenience and efficiency for your UDI management.

It provides you with comprehensive functions that you need to easily capture, manage, and report your UDI data to EUDAMED (optional + swissdamed and AusUDID). In addition, you get everything you need to make your quality management and UDI management efficient and fully compliant at the same time.

FULL Features

• Data volume: 100 UDIs are included in the FULL version, after which the pay-as-you-use model applies. The full version can be flexibly adapted to larger UDI volumes.
• Accounts: Access to the test and production system, for a maximum of 1 SRN
• Data management: Manage your UDI data, including all templates (MDR, MDD, IVDR, IVDD, AIMDD).
• Data import: Import your UDI data as an Excel file; you can also export your data via Excel.
• Data verification: Check your UDI data for completeness (EUDAMED Business Rules Check).
• Data transfer: Data transfer to EUDAMED Playground & Productive (XML bulk upload). The M2M function (direct connection to EUDAMED) can be booked additionally in the package.
• Onboarding: Comprehensive documentation package within the mytracekey self-service portal, including training material and FAQs.
• Data overview: The Task Manager keeps track of your tasks and lets you know 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: Annual contract
• Base Fee: €99/month, annual billing
• Additional Fees: €0.04/UDI for each additional UDI per month