UDI Data Distribution | GHX

UDI Data Distribution

As a medical device manufacturer, you’re aware of the U.S. Food and Drug Administration’s (FDA’s) unique device identification (UDI) rule, but submitting standardized product data to GUDID is only part of your challenge. You need to be able to synchronize product data with customers and business partners, ultimately preparing you for expected future global regulatory requirements.

The GHX UDI Data Distribution Solution provides you with a “Single Pipe” that allows both GUDID and GDSN data to flow into a single system. That system then distributes the data globally to the required end-user or global regulatory bodies.

This solution combines our UDI Submission service with GHX Health ConneXion, the only GDSN-certified data pool focused solely on the healthcare industry, while also providing GHX consulting experts who can guide you in meeting both current and future data submission needs.

GHX's key differentiators:

  • Combined GHX/PTC company expertise and viability
  • Technical architecture for managing submissions to the FDA, future global regulatory bodies, GDSN trading partners and eCommerce trading partners
  • Validated compliance with 21 CFR Part 11 requirements and 21 CFR Parts 820 and 830
  • Simplified transition of data via single inbound/outbound using .csv or XML file formats
  • Pre-verification of FDA UDI Submission
  • Submission monitoring and visibility to FDA acknowledgments, as well as rejection error processing workflows
  • Data synchronization engine source refresh
  • Ability to drive industry adoption of UDI to the point of use
  • Extensive professional expertise tailored to your specific implementation needs

GHX PROFESSIONAL SERVICES

In addition to extensive experience with both GDSN and UDI processes and requirements, our Professional Services team brings the practical experience of having worked in the healthcare industry as medical device manufacturers or members of providers or distributor organizations.  We are strong partners because we understand the business of our customers.  Our collaborative approach facilitates knowledge transfer over the duration of the initiative, building capabilities among your internal resources to achieve sustainable business processes.  

Our Professional Services practice has served Providers and Suppliers since 2005:

  • 20+ client service resources, all with prior industry experience
  • Supplier experience in eCommerce, standards, labeling, quality and manufacturing processes
  • Dedicated UDI / GS1 Standards readiness team
  • Customer-focused teams supporting all products and services
  • Deep understanding of regulatory compliance, as well as the business partners who will use your product data
  • Dedicated relationship executives and customer success managers (CSM)
Supplier Solutions

Complete this form to request more information or ask questions about our solutions and services. A GHX representative will contact you.

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