Upcoming Event Urges Medical Device Labelers to Act Globally
by Craig Hodgson, on August 2, 2016
Here in the U.S., as the Medical Device Industry continues to drive toward unique device identification (UDI) compliance—the next big deadline looms right around the corner—it's easy to lose sight of the bigger picture. But sooner or later, industry professionals will need to expand their scope and look at the international regulatory environment. And that’s exactly what we’ll be doing next week in Minneapolis, Minnesota, at the 4th Annual Medical Device Global Labeling Strategies conference on Aug 9 - 11.
Featuring thought leaders from global labeling, regulatory affairs and technical writing, the event is designed to clarify forthcoming global regulatory requirements, as well as to benchmark best practices in the consolidation of worldwide medical device labeling efforts. It promises to be a very worthwhile conference and just happens to coincide with ongoing efforts of some companies to adhere to current FDA labeling requirements.
If you’re in the business of manufacturing or supporting Class II devices as defined by the FDA's UDI regulations, hopefully you’re putting the finishing touches on your own program to comply with the next phase of regulations. September 24th marks the day when the labels and packages of Class II devices must bear a UDI with correctly formatted dates on the labels, and data for Class II devices must be submitted to the GUDID. Also, Class II standalone software must include its UDI as required by the mandate. In addition, Class III devices that are intended for reuse must bear a permanent marking on the device itself.
In a recent survey we conducted with about 120 professionals from the Medical Device Industry on UDI compliance, exactly 90% expect to meet requirements in time for the deadline, so that’s good news. But when we expanded the question to include compliance outside of the U.S, only 51% of respondents believe their current UDI barcode software solution will scale to meet international requirements. That’s not such good news—and points to a glaring need for this kind of event.
Attendees will have the opportunity to look ahead and examine the key challenges to sustaining global labeling strategies. The conference program will rely heavily on case studies and interactive discussions, featuring an expert panel of speakers who will discuss how to implement open-ended global labeling systems, optimize e-Labeling initiatives, as well as glean the latest insights surrounding international regulatory standards.
As part of the jam-packed agenda for the event, we’re honored to have our own Laura Johnson, Loftware’s Life Sciences Industry Specialist, present on Thursday, August 11 at 12:30 PM. Her session “Addressing the Challenges of UDI with Enterprise Labeling” will provide insight into how a standardized labeling solution that integrates with existing ERP systems like SAP and Oracle can ensure label accuracy throughout the extended supply chain. She’ll explain how real-world Medical Device customers are able to meet forthcoming global regulatory requirements—those same requirements that will be discussed at the confererence—while scaling to support high-volume customer label demands.
In addition, Laura will also bring to light a breakthrough solution developed in partnership with USDM Life Sciences that significantly reduces the time and cost of implementing a validated labeling solution—in many cases companies will save up to 50% in time and expense! Learn how you can streamline the process and realize the benefits of a standardized enterprise barcode labeling solution faster than ever before.
If you plan on attending the conference, please stop by the Loftware table and learn more about our enterprise labeling solutions for the Medical Device Industry—including the recently announced Loftware Validation Accelerator Pack, co-developed with USDM Life Sciences.
If you can’t make the event, check out our recent webinar addressing those same UDI survey results "Taking the Pulse of UDI Compliance" featuring USDM Life Science’s Jay Crowley, who is a recognized authority on UDI regulations and provides his own unique insight and analysis.