How UDI and UDI Data Can — and Must — Be Used for More Than Just Device Identification – Webinar Recording/Transcript
Medical device manufacturers: The FDA and other regulatory agencies are prioritizing supply chain solutions that provide seamless access to robust data across systems and outputs. Uniformity of unique device identifier (UDI), registration, and listing data across the global supply chain will create better access to critical device information for all stakeholders.
To understand how to properly use UDI systems, attend this FDAnews presentation led by Jay Crowley, an expert with more than 25 years’ experience at the FDA, most notably as senior advisor for patient safety in the Center for Devices and Radiological Health, where he developed the framework and authored key requirements for the agency’s UDI system.
Crowley, vice president of medical devices and solutions at USDM Life Sciences, explains the role that UDI systems and their associated data play as a foundation for solving emerging global regulatory, commercial, and quasi-regulatory use issues for your company’s medical devices.
- Learn how UDI systems are emerging globally
- Understand how UDI systems can be used to support regulatory and commercial purposes
- Master the FDA’s expectations for data alignment through UDI systems
- Recognize the need for alignment and reuse of data across various systems and outputs
To fully grasp the concept — and potential — of UDI systems and their associated product data for seamless online access for all stakeholders, don’t miss this chance to gain key insights from a top expert in the field.
Meet Your Presenter
Jay Crowley, vice president of Medical Device Service and Solutions at USDM Life Sciences, is an expert in business process, technology, and compliance solutions for the regulated life science industry. Most recently, Crowley was the senior advisor for patient safety at the FDA’s Center for Devices and Radiological Health. There, he developed the framework of and authored key requirements for the FDA’s UDI system. During his nearly 27 years with the agency, Crowley worked with design control regulations to reduce the chance of human errors with medical devices, patient safety, and adverse event reporting. He also worked in the Office of the Commissioner and the Office of Compliance at the FDA.
Who Will Benefit
- Regulatory affairs
- Supply chain
- Quality affairs
- Labeling managers
- IFU managers
- Medical affairs/clinical affairs representatives
- Project/program managers
- Medical device quality management system auditors
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Nov. 2, 2023