UDI Product Analysis (class III, FDASIA, II, I)

USDM Life Sciences helps many medical device companies analyze their product portfolio to assess the readiness for UDI Final Rule compliance. The assessment includes:

  • issuing agency standard (GS1, HIBCC, ICCBBA)
  • possible transition to new standards
  • packaging hierarchies
  • part marking and direct part marking
  • management of configurable devices
  • trays, kits and assignment management
  • trading partner labeling and registration guidance
  • UDI and standards (GS1, HIBCC, ICCBBA guidance)


  • 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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