Complying with UDI regulations from various regulatory bodies is a complex task. With the UDI Platform, you keep control of your UDI data at all times.
With our cloud-based UDI Platform, you can manage the data of your medical devices centrally in one place and exchange it directly with the regulatory authorities – flexible, simple, and compliant.
The UDI Platform is tailored to your needs and internal processes. It allows you to easily prepare data, quickly validate, and easily transfer your UDI data to the authorities. With the UDI Platform you always keep track of your data.
Stay on top of markets and UDI regulations. We make ensuring your UDI compliance easy. We constantly analyze the requirements of relevant markets and promptly implement changes. This ensures that your data is always up-to-date.
The UDI Platform can be seamlessly integrated into your existing system landscape, allowing you to incorporate existing data. A close integration with the authorities’ systems enables you to directly exchange data both, from and into the UDI Platform and your internal systems.
Dr. Antje Giffing, Head of Regulatory Affairs, Raumedic AG
Sebastian Deeg, Head of Information Technology, Raumedic AG
USA | FDA (GUDID) | AVAILABLE
✓ GUDID Data Model with all required attributes
✓ All validation and changeability rules
✓ Grace period handling
✓ Unlocking functionality for critical corrections
✓ Data submission to GUDID database
EUROPE | EC (EUDAMED) | AVAILABLE
✓ EUDAMED Data Model with all necessary attributes for MDR/IVDR
✓ All validation and changeability rules
SOUTH KOREA | MFDS (IMDIS) | AVAILABLE
✓ IMDIS Data Model with all necessary attributes
✓ All validation and changeability rules
✓ Data submission to IMDIS database
CHINA | NMPA (CUDID) | AVAILABLE
✓ CUDID Data Model with all necessary attributes
✓ All validation and changeability rules
✓ Data submission to CUDID database
SAUDI ARABIA | SFDA (SAUDI-DI) | AVAILABLE
✓ SAUDI-DI Data Model with all necessary attributes
✓ All validation and changeability rules
✓ Data submission via SFDA Excel template
TAIWAN | TFDA (UDID) | AVAILABLE
✓ UDID Data Model with all necessary attributes
✓ All validation and changeability rules
✓ Data submission via TFDA Excel template
AUSTRALIA | TGA (AusUDID) | IN PILOT PHASE
More information to follow as soon as Content Package is available.
SINGAPORE | HSA (SMDR) | AVAILABLE SOON
More information to follow as soon as Content Package is available.
Active monitoring and rapid implementation of new UDI requirements
Reuse existing data for new markets
Configuration and automation of processes for faster UDI compliance
Global and scalable concept for upcoming UDI regulations
Experienced team of experts for global UDI compliance
Learn how to stay GxP-compliant in the cloud.
