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.
The Soom platform creates a data fabric later to facilitate rapid data collaboration 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. With even more regulations coming around the globe, this divergence between regulations is not expected to end. Soom is uniquely built to help clients weather upcoming 10-year tsunami of global harmonization regulations.
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 uses semantic search and augmented data management to create the data fabric needed to harmonize data models, elements, and definitions. Mapping this information, the Soom platform enables interoperability between diverse stakeholders in the healthcare value chain, from manufacturers, to healthcare providers, to patients.
Soom Data Fabric
- Unlocks supply chain constraints and minimizes inefficiencies
- Eliminates significant costs in middleware, custom solutions
- Ensures global trade compliance despite the complex regulatory environment
System and User-Friendly Workflows
- Ensure product labeling accuracy around the world
- Gather and prepare data for regulatory submission
- Deliver Electronic Instructions for Use (eIFU)
By combining the power of semantic search and augmented data management, Soom enterprise solutions solve product master data challenges resulting from global trade compliance complexities.
Interested in optimizing global trade compliance and product labeling accuracy? Contact Soom.