Regulatory bodies, device manufacturers, healthcare providers and numerous other stakeholders are gearing up for global implementation which presents its own specific challenges and opportunities. Adherence to specific regulatory specifications, both in labelling and packaging as well as data is a must, but in an increasingly competitive market, achieving compliance while maintaining a competitive edge and assuring ROI is paramount. This Seminar will highlight the state of urgency in the industry, address implementation challenges - plus maximize the ROI of your UDI implementation in the future, ensuring it continues to drive business value.
* Details on industry conversations and customer relationships that are defining UDI discoveries and driving UDI adoption
* The influence of UDI across the healthcare eco-system; from point of manufacture, to point of consumption, and downstream to the clinical registries
* Global UDI-related standards development and how your organization can harness harmonization efforts
* Specific implementation guidance for the EU MDR & IVDR Regulations
* Stakeholder activities concentrated on the quality, usefulness, accuracy, and management of the data within the GUDID
Who Should Attend?
* Medical Device Manufacturers
* Health Care Distribution/Group Purchasing Organizations
* Hospitals and Health Care Providing Organizations
* Health Care Industry Professionals
State of the UDI Regulation | Steven Luxenberg, U.S. Food & Drug Administration
Unleashing the Potential of Medical Unique Device Identification | James Tcheng, Duke University Health
Challenges with UDI Implementation | Jay Crowley, USDM and Dennis Black, BD
UDI Panel – Vision and Reality | Patti Blessing, CAVU; Terrie Reed, Symmetric; Natalia Wilson, Arizona State University; Olga van Grol-Lawlor, Boston Scientific