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Unique Device Identification

Unique Device Identification

UDI: A Guide to Device Identifiers

UDI Post Submission

Reed Tech UDI Solutions

Does UDI matter when it comes to Reimbursements?

Is your supply chain process prepared for reimbursement scenarios? Traditional Class I, II, III medical devices and even some ‘specialty’ accessories (like unique packaging mechanisms) need a product data management strategy that includes reimbursement considerations...

What is a GLN (Global Location Number)?

Global Location Number (GLN) How does the supply chain keep ‘order’ in identifying locations and functions? The identifying key to determine the ‘where’–physical/digital location and the ‘who’—a function and or legal entity is the GLN. Global Location Number...

Reed Tech Insights – UDI and Class I Medical Devices

Reed Tech presented at the recent Pharma and Device Packaging and Labeling West Coast Conference in Burlingame, California. To see some quick insights, download the slides on Placing UDI on Class I Medical Device Labels and Reporting UDI Data to the FDA GUDID by...

Happy New Year! Holiday Schedule

Due to the impending December 31 deadline for Establishment Registration and Blanket No Change Certification submissions, we are currently processing an extremely high volume of SPL conversion orders. Accordingly, to guarantee delivery by December 31, we must receive...

510(k) and Medical Device Safety News

Ongoing media attention concerning medical device safety and quality is causing many to question whether there is a need to reform the 510(k) clearance process. Nearly 20% of current 510(k)s are cleared based on predicates that are more than 10 years old, according to...

Webinar: From UDI to GDSN-Are You Ready?

Listen to medical device data experts from Reed Tech to learn about the benefits of putting your UDI to practical use and the importance of preparing your data now for GDSN and anticipated commercial data exchange requirements. Learn how a manufacturer can pivot from...

K2M Case Study: Tackling UDI and What Comes Next

Mark Zellers, Quality Assurance Specialist at K2M, is responsible for ensuring his company’s data is accurate and kept up-to-date with all sorts of outside stakeholders. One of his colleagues handles internal data management and Zellers ensures it gets to the people...

Don’t Forget—Medical Device Data Submission Deadlines in 2018

Beginning in September of 2014, medical device manufacturers have faced a series of data submission and maintenance requirements from the FDA as part of its Unique Device Identification (UDI) initiative. The agency phased the compliance deadlines by device class,...

Webinar: Harmonizing your EU MDR Efforts with FDA UDI

Gary Saner and John Lorenc of Reed Tech discuss UDI requirements in the EU and how device companies can align their EU compliance efforts with existing FDA UDI programs. WATCH NOW FOR: EU MDR / IVDR Overview EU UDI Requirements and Comparison to FDA UDI Global Data...

FDA is Sharpening its Focus on UDI Data Quality

In recent months, the Food and Drug Administration has continued to build on its message of the importance of data quality in its Unique Device Identification database, the GUDID. In a recent presentation to the Dental Trade Alliance, FDA GUDID Program Manager Indira...

Webinar: UDI and the EU MDR: What You Need to Know

In this webinar, you’ll get an overview of the requirements for the upcoming Unique Device Identification (UDI) initiative in the EU from Reed Tech and PRISYM ID team members. Presenters Chris Lentz, Gary Saner and Phil Dray will address the following: EU MDR /...

UK NHS eProcurement: The What, Who, Why and When

If your organization markets medical devices in the United Kingdom, you may have heard about the National Health Service (NHS) eProcurement program. Sometimes loosely referred to as the “U.K. UDI,” eProcurement shares some traits with FDA’s UDI program, but is quite...

FDA Insight: UDI Data Quality

On June 7 and 8, the medical device industry joined the FDA for the ninth Annual UDI Conference. With a recent UDI extension for Class I device labelers, industry members had an increased interest in FDA’s commentary on the state of the UDI mandate. During the two-day...

UDI Update: New FDA GUDID Technical Documents Released

Did you know that FDA recently updated some technical documents related to GUDID submissions? On March 31, the agency sent an email to its list of GUDID email subscribers with links to an updated GUDID Data Elements Reference Table and GUDID HL7 SPL Implementation...

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