Tuesday, April 14, 2015
Data Quality is Critical for UDI Compliance
Posted by Jeff Russell
Implementation for the FDA’s unique device identification (UDI) system for medical devices is underway. In 2007, Congress passed legislation requiring the establishment of a UDI system for all regulated medical devices. The goal was to improve patient safety by enabling teams to identify devices and correct problems faster. Medical device manufacturers must now start considering how to accommodate this UDI compliance.
Final rules were set with requirements around labeling, direct marking, and data submission. After some industry feedback to adjust for implanted devices and single-use products, the rules were finalized and staggered compliance deadlines set for different classes of devices.
As the UDI system is fully implemented, the process will evolve to continually improve efficiency. Manufacturers need to establish systems now to continue evolving with updates to UDI compliance rules. According to the article For UDI Compliance, Data Quality is Critical, “With rollout of the system underway, manufacturers need to assess their own level of UDI readiness, including their ERP and other systems, and start working toward meeting their requirements. By building an efficient UDI process now, they will be better equipped to generate and manage high-quality data as the UDI system evolves and matures.”
Read the full article by Jeff Russell, Practice Leader for Armanino’s High Tech and Life Sciences Industry Practice: For UDI Compliance, Data Quality is Critical.
Jeff leads Armanino’s Dynamics Business Solutions and Industry practice with focus on High Tech and Life Sciences Manufacturing. Over the past eleven years, Jeff has implemented business systems for more than 20 engagements in semiconductor, electronic device, medical device, pharmaceutical/nutraceutical and other regulated environments.