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Medical Device Product Data Management

Medical Device Product Data Management

UDI: A Guide to Device Identifiers

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

Reed Tech SingleSource™ for Medical Devices

A Closer Look at FDA Convenience Kits: Which Need UDI? Which Don’t?

A Closer Look at FDA Convenience Kits: Which Need UDI? Which Don’t?

Pop quiz: For the purposes of FDA Unique Device Identification (UDI), is an anterior cruciate ligament (ACL) procedure kit considered one medical device, i.e., a “convenience kit?” That question is one of many addressed by the FDA’s final guidance on Unique Device...

Video: EU UDI – Q&A with Gary and John

Video: 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

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...

Blog: 3 Ways to Simplify UDI and GDSN Data Management

Blog: 3 Ways to Simplify UDI and GDSN Data Management

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?

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...

White Paper: Global & EU UDI Data Management Challenges & Solutions

White Paper: Global & EU UDI Data Management Challenges & Solutions

The UDI product data submission process can be arduous without the right expertise and tools. Failures in the process can have a significant, negative impact on a medical device manufacturer’s bottom line. In light of regulatory and marketplace demands, proactive...

Does UDI matter when it comes to Reimbursements?

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)?

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...

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