This site uses modern web standards that aren't supported by your browser. For best results, please upgrade to Google Chrome, Microsoft Edge, or Mozilla Firefox.

Unique Device Identification

Unique Device Identification

UDI: A Guide to Device Identifiers

UDI Post Submission

Reed Tech UDI Solutions

EU UDI – Q&A with Gary and John

If you are looking for useful desktop references concerning EU UDI, you have come to the right place. Reed Tech recently hosted a webinar discussion that included insights on what is currently known about EUDAMED requirements. The speakers covered detailed slides on...

Reference Doc: FDA & EU UDI Data Elements List

Are you tracking all the news about the latest developments for EUDAMED requirements? We are too! We continue to add insights concerning what to expect as EU UDI/EUDAMED requirements are published. For your quick reference and documentation, we have created a list of...

3 Ways to Simplify UDI and GDSN Data Managment

Tracking and Tracing Medical Devices: 3 Ways to Simplify Your UDI and GDSN Data Management By: John Lorenc, Senior Manager Regulatory Solutions — Life Sciences Reed Tech The challenge of tracking medical devices throughout the health care supply chain and delivery...

Video: How is BUDI-DI different from UDI-DI?

Basic UDI-DI or BUDI-DI has a unique history in the industry, causing some confusion with the definition. In this episode of Reed Tech Insights, our resident UDI guru, Gary Saner, walks through a comprehensive history, definition and solid examples to provide a...

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,...

By continuing to use the site, you agree to the use of cookies. more information

The cookie settings on this website are set to "allow cookies" to give you the best browsing experience possible. If you continue to use this website without changing your cookie settings or you click "Accept" below then you are consenting to this.

Close