UDI Regulatory Guidance

USDM Life Sciences, under the direction of Jay Crowley the architect of the UDI Final Rule while at the FDA, provides in-depth review of your company’s

  • products
  • current identification standards
  • current labeling and packaging
  • current state regarding the GUDID data collection, data management and device registration
  • current business practices

USDM's in-depth review provides the basis for supporting your company’s plans and projects to become compliant with the UDI Final Rule. The USDM UDI team offers guidance on establishing your UDI regulatory policy, product labeling and packaging, transition to new identification standards, support for registering devices in the FDA GUDID, adoption of best practices to achieve and maintain compliance with the Final Rule and program management structure to support your execution.


  • 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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