Get UDI Labeling on Fast Track to Validation, Optimization

by Craig Hodgson, on June 2, 2017

Billed as “the ONLY event dedicated to guidance and training for those impacted by the UDI Regulation,” the annual UDI Conference takes place next week on June 6-7 at the Hilton Baltimore in Baltimore, MD. And while the key FDA deadlines for Class II and Class III devices have come and gone, there’s still a lot of value in attending this two-day event.

The UDI Conference typically attracts medical device manufacturers, distributors, GPOs, and hospital systems that are impacted by the regulation. This year the sessions will extend beyond some of the fundamental “nuts and bolts” of UDI readiness from previous years and instead focus on best practices to help attendees expand and improve their UDI programs. Some of the key topics to be covered include:

  • The role of FDA in UDI adoption and the growing commitment by industry groups
  • How UDI impacts customer relationships, market positioning, and operational efficiencies
  • The influence of UDI across the healthcare eco-system; from point of manufacture, to point of consumption, and downstream to the clinical registries
  • UDI-related standards development in multiple industries and global UDI harmonization efforts

Another key challenge for medical device companies that will be addressed is the lengthy validation process required for implementing solutions to meet FDA-mandated regulations like UDI. Depending on the workflow and products used, labeling validation, in particular, can be draining on organizations as every department from Quality and Marketing to Logistics needs to get involved and on the same page. That’s where a partnership between Loftware and USDM Life Sciences comes into play.

Just last year, Loftware and USDM launched the Spectrum Validation Accelerator Pack (VAP) to dramatically reduce the time and cost of implementing a validated, compliant medical device labeling solution. By up to 50%. It’s the only VAP for enterprise labeling and provides a set of content-rich templates that can be configured to help you meet critical phases of testing and qualifying UDI labeling. It also enables you to validate and experience, more quickly, the industry’s most powerful, scalable labeling platform. Are you really all set with UDI compliance? How well are suppliers, distributors and providers integrated with your process? Are you still seeing costly errors, delays and miscommunication with your UDI label software?

If you’re going to the UDI Conference, stop by our booth to hear how customers are aligning labeling to their existing business processes—faster than ever imagined—to not just comply with UDI, but drive measurable gains in supply chain efficiency.

If you can’t make it to the show, take a quick peek at the Spectrum VAP data sheet to learn more. And then contact an expert from Loftware or USDM Life Science to get started with your labeling validation project. We make it easy.

Here's more information on UDI and how it affects labeling in the supply chain.

Medical Device VAP


Topics:Medical DevicesRegulatory