Handle the complexity of multiple markets with one platform

Available Content Packages

US | FDA (GUDID)

Available

The Content Package includes the GUDID data model with all necessary attributes, validation and changeability rules and the submission handling with GUDID.

EU | EC (EUDAMED)

Available

The Content Package includes the EUDAMED data model with all necessary attributes for MDR / IVDR incl. Basic UDI handling and legacy devices. It is delivered with all validation and changeability rules and the submission handling with EUDAMED (to follow as soon as available at EC).

South Korea | MFDS

Currently under development

Release available in Q4 2020.
Contact us for more information.

China | NMPA

Currently under development

Release planned for first half of 2021.
Contact us for more information.

Saudi Arabia | SFDA (Saudi-D)

Currently under development

Release planned for first half of 2021.
Contact us for more information.

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