A guide to incorporating UDI into your overall quality, compliance and risk management strategy
Achieving FDA UDI compliance is not just about the label. This is just one element in the wider process of effectively managing data within the production process. With a high percentage of voluntary recalls of medical devices caused by labeling and packaging defects, it’s easy to see how the label becomes the focus. The implications of product recall are significant; efficiency, productivity, and ROI take a major hit, while the potential damage to brand reputation and patient safety are equally severe. However in striving to deliver safe, accurate and compliant product information, it’s not just about the label-it’s all about the data.
By taking a 360 view organizations can ensure that they capture, store, and disseminate data safely, quickly, and accurately. Centralized data creates a robust platform for a “single version of the truth†that can be used to support UDI compliance and provide an audit trail, ensuring the right information goes on the right product at the right time, every time.
Attend this webinar to learn more from PRISYM ID’s Hal Plant, and industry expert Jay Crowley, Vice President of UDI Solutions and Services at USDM, about how effective data management can drive UDI compliance and deliver significant productivity benefits.
Presented by
Jay Crowley,
VP of UDI Solutions and Services, USDM
Jay Crowley is the Vice President of the Unique Device Identification Practice. Jay was most recently Senior Advisor for Patient Safety in the Food and Drug Administration’s Center for Devices and Radiological Health. Jay developed the framework and authored key requirements for FDA’s Unique Device Identification system.
Hal Plant,
US Business Development Manager, PRISYM ID
Hal Plant has over 10 years of experience in helping medical device and life science organizations achieve greater control, visibility, and efficiencies throughout their labeling operations while ensuring FDA compliance. His cross-functional knowledge and insight helps clients identify both potential risks and opportunities for improvement within their labeling processes.
