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Medical Device Safety and Quality

 

Global Data Synchronization Network (GDSN)

UDI and Product Data

Drug  & Biologic Product Submissions

Recent Blog Posts

What is a UDI label and UDI requirements?

What is a UDI label and UDI requirements?

What is UDI? Unique Device Identification is a globally unique, unambiguous identification comprised of a Device Identifier (DI) and a Production Identifier (PI).  UDI is specific to a device model...

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Status Update for Australia TGA UDI

Status Update for Australia TGA UDI

Is Australia Therapeutic Goods Administration (TGA) making progress on Unique Device Identification (UDI) requirements? The answer is yes! There are several progress milestones that have been...

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FDA GUDID Class I Reminder

FDA GUDID Class I Reminder

What are the requirements for Class I medical devices concerning unique device identification (UDI) data submission to US FDA GUDID? First off, what is the Global Unique Device Identification...

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Customer Q&A: OMUFA Update

Customer Q&A: OMUFA Update

Recently, Reed Tech has been receiving many questions from our Pharma customers regarding the Over-The-Counter Monograph User Fee Program. As a response, we enlisted our colleague and friend,...

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