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 (IMDIS)

– Available –

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

China | NMPA (CUDID)

– Available –

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

Saudi Arabia | SFDA (Saudi-DI)

– Currently under development –

Release planned for first half of 2022.
Contact us for more information.

Request Demo