Innovation for Complex Global Regulations
With ever expanding global regulations, such as Unique Device Identification (UDI) and Medical Device Regulation (MDR), medical device manufacturers are faced with increased complexity and inefficiency due to regulatory compliance. To be competitive, medical device manufacturers must understand that unique device identification is not an ad hoc regulatory project, but an integral part of enterprise operations system that is the basis for ongoing global regulatory changes.
Soom is a future-proof solution that reduces product data errors while maintaining global trade and regulatory compliance.
Get Ready for Medical Device Regulation (MDR) and Beyond
While the expanding global regulations, like Europe’s MDR, take guidance from existing regulations like, the United States’ FDA UDI, there are still numerous differences. This divergence between regulations is not expected to end with new regulations coming around the globe.
With an eye towards this complex and evolving future, the Soom platform is innovative and uniquely flexible enough to help manufacturers rapidly comply with regulations and deliver products around the globe. Soom does not centralize ownership of data, but instead leverages existing sources and processes from across the value chain to harmonize data models, elements, and definitions. Mapping this information, the Soom knowledge graph enables interoperability between diverse stakeholders in the healthcare value chain, from manufacturers, to healthcare providers, to patients.
Data Harmonizing and Cleansing Platform
- Unlocks supply chain constraints and minimizes inefficiencies
- Eliminates significant costs in manual processes
- Ensures global trade compliance of products
System and User-Friendly Workflows
- Ensure product labeling accuracy
- Validate GS1 compliance
- Available for worldwide consumption
By combining the power of the cloud and mobile scan, Soom enterprise solutions solve master data challenges resulting from global trade compliance complexities.
Interested in optimizing global trade compliance and product labeling accuracy? Contact Soom.