Life Sciences Blog

Webinar Recording: Challenges and Considerations for Building Your Own UDI Solution

Jun 26, 2019 | Global Data Synchronization Network, Life Sciences, Unique Device Identification

Is your team evaluating UDI regulatory submissions for EU and other regions? 

All the complexity around UDI regulatory (and commercial) requirements across the globe create serious challenges for product data management. When considering what’s at stake, a discussion with those who have taken on the ‘build’ challenge and learned some hard lessons is a good place to start.

In this informative presentation, hear some wisdom and explore all the options when it comes to UDI submissions for FDA, EU and other global regulators. The featured speakers each have a long tenure in the UDI solutions environment. From the start of the first FDA UDI mandate back in 2014 to the imminent EU UDI regulations, they have experienced the highs and lows of resolving the known and unknown in UDI data management and submissions.

Here’s a short excerpt of the presentation:

Review these key topics:

  • The global UDI landscape – EU is just the next domino to fall in this game
  • Hear about the challenges and considerations for building your own system
  • What does it take to build and maintain a system for the long haul?
  • Resource and budget implications – initial and ongoing
  • Review the key risks of going with a vendor solution-are they really risks?

Of interest to:

  • IT professionals
  • Software Development professionals
  • Product Information Managers
  • Regulatory and compliance officers
  • Quality control and quality systems officers
  • Data management and statistics personnel
  • Manufacturing directors and supervisors

To access the entire presentation, please let us know who you are. Thanks in advance! We hope you and your team find the content valuable.

Comments or questions? email us: [email protected]

If you would like to download the slides from this presentation, click here

About LexisNexis Legal & Professional

LexisNexis Legal & Professional® provides legal, regulatory, and business information and analytics that help customers increase their productivity, improve decision-making, achieve better outcomes, and advance the rule of law around the world. As a digital pioneer, the company was the first to bring legal and business information online with its Lexis® and Nexis® services. LexisNexis Legal & Professional, which serves customers in more than 150 countries with 11,300 employees worldwide, is part of RELX, a global provider of information-based analytics and decision tools for professional and business customers.

About LexisNexis Reed Tech

LexisNexis Reed Tech brings clarity to innovation for businesses worldwide. We enable innovators to accomplish more by helping them make informed decisions, be more productive, comply with regulations, and ultimately achieve a competitive advantage for their business. Our Reed Tech suite of SingleSource™ for Medical Devices, SingleSource™ for Drug Products, and Navigator™ for Drug Labels enables life sciences companies to create product data management strategies and meet compliance deadlines on time. We are proud to directly support and serve these innovators in their endeavors to better humankind.

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