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Case Study

K2M: Tackling UDI and What Comes Next

Mark Zellers, Quality Assurance Specialist at K2M, gives industry members an overview of how his organization approached the challenge of UDI data submission to FDA. 

Download the case study to learn about: 

  • The challenges presented by the UDI data submission mandate
  • Why K2M chose the UDI system by Reed Tech as their solution
  • How K2M handles new challenges, such as GDSN requests and EU MDR
  • Learned lessons to share with device industry members