supplier labeling

Five common challenges to supplier labeling – and how to solve them

Mari Waldron Industry news Leave a Comment

In working with our customers to digitally transform their labeling, we see firsthand the challenges they face when trying to extend their standardized, digitally-transformed labeling process to their suppliers.  Here are the five most common challenges we see (and how we solve them): Challenge #1: Suppliers often have vastly different IT infrastructures and varying levels of technical knowledge. Their IT …

label management in manufacturing

Streamlining label management in the manufacturing sector

Ken Moir Industry news Leave a Comment

Unsurprisingly, labeling is not a subject which is often focused upon in the busy world of manufacturing. Yes, it’s seen as important, but there are myriad other factors that shape success in the industry. As a result, many organizations’ have disparate or legacy systems which are a huge burden on IT. For instance, it is common for each distribution center, …

Medical device

European Medical Device Directives – How a small-medium sized medical device company responded to the new regulations

Susan Gosnell Medical Devices Leave a Comment

The medical device directives are currently being revised by the EU’s institutions in a process that began in 2008. This revision has the following objectives: To ensure a consistently high level of health and safety protection for EU citizens using these products To maintain the free and fair trade of the products throughout the EU To adapt legislation to the …

Helpful resource in planning for September UDI deadline for Class II device compliance

Susan Gosnell Medical Devices Leave a Comment

Manufacturers of Class II medical devices must comply with the FDA’s Unique Device Identifier (UDI) regulations by September 2016, the latest in a series of deadlines for varying devices. Are you ready? The FDA manages a Global Unique Device Identifier Database (GUDID), to which manufacturers must submit their device details, via one of three accredited agencies. There is a fair …

Who bears responsibility for submitting UDI data to the GUDID

Who bears responsibility for submitting UDI data to the GUDID?

Reed Tech Medical Devices Leave a Comment

The FDA has specified in its Final Rule on Unique Device Identification (UDI) that medical device labelers marketing their products in the United States are required to submit data records to its Global Unique Device Identifier Database (GUDID, pronounced “Good-ID”). Which company qualifies as the device labeler? The next question to ask is which company (or companies) involved in bringing …

Highlights from the UDI Conference 2016 and Medical Device and Diagnostic Labeling Conference

Susan Gosnell Medical Devices Leave a Comment

In late April I attended a couple of medical device industry conferences which were both eye-opening in different ways. The looming issue of UDI compliance was at the heart of both conferences, though they took contrasting approaches. UDI Conference 2016, Baltimore MD, April 18-19 This was an official FDA-sponsored event, where a large number of delegates from medical device manufacturers, …