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. You can also use the price calculator to calculate your individual price for the FULL, EUROPE, and PREMIUM versions. Or you can use our interactive tool, the CompliMate, to perform a UDI compliance check.
The trial version allows you to try out the functions of the software yourself and find out whether the requirements are met. You can easily switch to a higher category from this version. The data you have already entered will be retained.
FREE Features
Pricing
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
The FULL extension for Europe and more UDIs. The swissdamed compliance module is included, as is EUDAMED M2M reporting. The AusUDID module can also be added.
EUROPE Features
Pricing
Do you have multiple business units (SRN) and want to use M2M for data transmission to EUDAMED? Then our Premium package is perfect for you.
PREMIUM Features
Pricing
The ENTERPRISE package is ideal for those seeking a long-term, strategic partnership while managing over 3,000 UDIs.
ENTERPRISE Features
Pricing: On request
The fastest way to transfer your data to EUDAMED: With the M2M connection, you can transfer your UDIs directly from UDI Manager to EUDAMED. The data is transferred directly via a secure connection and an audit-proof transfer log is created. This connection is worthwhile even for smaller amounts of data.
[M2M can be added as an option to mytracekey UDI Manager FULL; it is included in EUROPE, PREMIUM, and ENTERPRISE].M2M Features
Pricing
The easiest way to prepare your EUDAMED data for the Swiss database. Secure and fast, thanks to business rule checks for swissdamed and simple data conversion.
[The module can be added as an option to mytracekey UDI Manager FULL and PREMIUM; it is included in EUROPE.]swissdamed Compliance features
Prices
The best way to prepare your data for the Australian database. Secure and fast, thanks to Business Rule Check for AusUDID and an M2M connection.
[The module can be added as an option to mytracekey UDI Manager FULL, EUROPE and PREMIUM]AusUDID Compliance features
Prices