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K2M Case Study: Tackling UDI and What Comes Next

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Mark Zellers, Quality Assurance Specialist at K2M, is responsible for ensuring his company’s data is accurate and kept up-to-date with all sorts of outside stakeholders. One of his colleagues handles internal data management and Zellers ensures it gets to the people who need it outside K2M. A big challenge facing his team came in 2015, when labelers of Implantable, Life-Supporting, of Life-Sustaining (IL/LS/LS) devices faced a compliance deadline from FDA to assign Unique Device Identifiers (UDIs) to their products, update their labels and submit the data records to the agency.

Now, Zellers and his teammates face additional demands for their product data. Customers are requesting data through the Global Data Synchronization Network (GDSN) for use in their product catalogue systems, the National Health Service (NHS) in the U.K. is requesting a similar, but distinct, dataset for their eProcurement program and the new EU MDR data submission requirements loom large on the horizon. Zellers spoke with the team at Reed Tech® to share his challenges and lessons learned from the approach K2M is taking to ensure the data needs of all its downstream stakeholders are being met.

This is an excerpt from a larger case study. You can access the full document here.

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