UDI Program Design and Execution

USDM Life Sciences offers complete UDI program planning and implementation services to address each company’s unique product mix, IT environment, supply chain structure, labeling and packaging capability and resource availability.

USDM’s UDI program framework is structured as follows:

Analysis, Strategy and Planning

  • Determine FDA UDI requirements impact by device and organize products by: class, market, production location, CPO, label and packaging components
  • Analyze gaps between FDA requirements and current labeling/packaging for each product
  • Determine your FDA-accredited organization for assignment of UDIs and auto ID barcode
  • Analyze gaps between current PLM, connectivity to GUDID, labeling/packaging/inspection and supply chain systems and requirements for UDI
  • Establish the strategy and plan (activities, schedule, budgets, responsibilities, partners) to:
    • Collect UDI data for the GUDID and remediate gaps in labels and packaging
    • Develop the interface to GUDID
    • Remediate Product Lifecycle Management (PLM) and supply chain systems, labeling/packaging equipment and processes
    • Establish validation and compliance strategy and plan

Build and Execute

  • Update product label/packaging design and materials – sequence by compliance date
  • Design, develop, implement and validate IT system changes and interfaces
  • Purchase or enhance printing, labeling, packaging equipment and validate
  • Execute dry runs to update GUDID and confirm capability of equipment, systems, and processes
  • Develop production SOPs and execute process validation

Commercialization

  • Manage the cutover to production for the first run of each product
  • Incorporate UDI requirements into new products and new versions of existing products
  • Registration of new products and new versions of existing products with the GUDID

 

 

 

Testimonials

  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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