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Good People Working on Good Projects with Good Process

Case Study 1: Unique Device Identification (UDI)

Situation Medical device class II low risk manufacturer was updated labeling per UDI regulation and called on Frestedt Inc. to train and project manage the implementation.
Frestedt Approach
  • Provided training in partnership with subject matter experts
  • Created project plan and tracking efforts for cross function teams to meet the required deadline
  • Engaged venders and supported vender management activities
  • Selected needed equipment (e.g., bar code verification systems) to meet regulations set by accredited FDA issuing agencies
Results Frestedt Inc. provided all necessary equipment, documentation and training to allow the client meet UDI regulations.