An exclusive blog, sponsored by Loftware, devoted to labeling issues that affect your business in an ever-changing global economy.
Posts tagged "UDI"

Industry Analyst Says UDI a High Cost, Low Return Initiative

For years and years, big technology companies have been walking in to major industry analyst firms and ordering up some research. Still, it never ceases to amaze me just how often the research results favor the company footing the bill. Now I’m not saying that is how or why a recent article got written by an...

Will Looming FDA UDI Mandates in Healthcare Lower Supply Chain Risks?

Writing for Logistics Viewpoints, Steve banker poses an interesting point based on a common assertion among supply chain professionals. Here’s how he puts it: Supply chain managers often bemoan increasing regulation, and how new regulations or overly stringent oversight increases supply chain costs and makes their day-to-day jobs more complex. Sound familiar? But is it...

Becton, Dickinson and Company Confirms GS1 Advocacy and Looks Ahead to UDI

You’ve heard of Becton, Dickinson and Company, right? Yahoo Finance reports the medical technology company currently employs 29,116 people developing, manufacturing, and selling medical devices, instrument systems, and reagents worldwide. In a recent news release, the company mentioned something else it is doing, and has been doing worldwide: supporting and using GS1. Here’s why:

The Future of Medical Device 'Game Changers'

Maybe you’ve heard the name Joshua Makower? According to a recent story out of Minneapolis, he’s a medical doctor with an MBA from Columbia University and an engineering degree from the Massachusetts Institute of Technology who has founded — and successfully spun off — three med-tech companies, most recently Acclarent Inc., which was sold to Johnson...

UDI Perspectives and Timetables Explained by FDA Senior Advisor in Recent Article

This is an important update to the Food and Drug Administration’s (FDA) timelines for UDI (Unique Device Identification) implementation deadlines. It comes by way of a recently published article entitled, “The FDA’s Take on Unique Device Identification,” authored by Jay Crowley who is senior advisor for patient safety for the Food and Drug Administration’s Center for Devices...

A ground-breaking white paper: Compliance with UDI Labeling Mandates: A Proven Methodology

We have a brand new and very compelling White Paper just out. Compliance with UDI Labeling Mandates: A Proven Methodology, was produced because, as the introduction states: There has never been a better or more urgent time for manufacturers of healthcare products to make a close examination of their product labeling systems. If you read...

Annual Cost of Foodborne Illness in US: $152 Billion

Thanks to a recent initiative of The Pew Charitable Trusts, for the first time in American history someone has finally put a price tag on what it costs people in the United States each year who get sick from bad food. After crunching all the numbers, the grand total comes to $152 billion (yes, that’s...

Loftware's UDI Webinar #3 on Feb. 9th: "Step 2: Integrate – Managing Your Labeling Data Systems Effectively"

For the third in our series of webinars, which occurs February 9th at noon eastern time, the attention will be on these core questions: “How do I get started? Where do I start? How do I tackle today’s problems, yet stay ready for future compliance changes?” We’re tackling these questions because when you’re involved with...

Report on FDA's Prototype UDI Database Apt to Spur Questions at our Jan. 12th Webinar

This is very interesting. At the FDA News web site you’ll see a brief item entitled, “Devicemakers Question Data Requests for FDA’s Prototype UDI Database.” The first sentence seems to imply there may be much work ahead to finalize a UDI approach that satisfies everyone. The sentence is: Devicemakers testing a unique device identifier (UDI)...