Common UDI label mistake: The barcode prints over the edge of the label

UDI labeling: common mistakes and best practices

Marko Vrbnjak Medical Devices Leave a Comment

There’s no doubt that UDI is a hot topic among medical device manufacturers. They are currently under pressure to comply with the FDA’s UDI requirements. Europe plans to introduce similar rules that companies will need to adhere to in the next three to four years. Other countries like Brazil, Turkey and China are introducing their own rules. It’s clear that …

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 …

Speach at UDI compliance conference

Europe is closely watching UDI

Marko Vrbnjak Medical Devices Leave a Comment

The conference was a UDI-dedicated networking and learning meeting for device manufacturers and healthcare providers. The focus was on how they can support each other to benefit the patients. I recently attended and presented at the UDIs & Traceability for Medical Devices Forum in Munich. A prominent theme at the event was technology and how compliance to UDI and other …

UDI issuing agencies

How to Choose a UDI Issuing Agency

Marko Vrbnjak Medical Devices Leave a Comment

With the advent of compulsory Unique Device Identification (UDI) for medical device labels, companies in the sector must select a device identifier issuing agency. The device identifier itself – a numeric or alphanumeric code – must include a device component identifying the labeler and the particular version of the device, as well as a production component, which identifies the individual …

Process Optimization – the NiceLabel Solution

Susan Gosnell Industry news Leave a Comment

Process Optimization – the NiceLabel Solution Lower costs, greater responsiveness, more efficient compliance, easier data management…the list of advantages that NiceLabel offers its customers takes Lee Patty, Vice President and General Manager for the Americas, a while to get through. “The main thing we offer is process improvement,” says Patty from his base in Wisconsin. “We take a consultative approach, …

Krka gets SMART

Marko Vrbnjak Pharmaceutical Leave a Comment

In search of world class efficiency performance, leading European pharma company Krka recognized that its international expansion ambitions depended upon having the best data management technology. Label data management was a crucial part of Krka’s operations and with thousands of products distributed to at least 70 countries worldwide, labeling had become a challenge for the company. The company’s label catalog …

It’s War! Smart Manufacturing and the Fourth Industrial Revolution

Marko Vrbnjak Industry news Leave a Comment

We are at the beginning of a manufacturing arms race. The European Commission recently announced a €2 billion investment into ‘Factories of the Future’. President Obama earmarked US$1 billion for a network of 15 manufacturing innovation institutes across the US. At stake is a huge portion of global trade. Figures suggest that 30 per cent of US imports from China …

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, …

AIDC Industry Trends, AIDC Industry

2016 predictions for the AIDC industry

Ken Moir Industry news Leave a Comment

By Ken Moir, Marketing Director, NiceLabel SMBs and large enterprises alike are making a big shift toward legacy system modernization.  A key component of these modernization initiatives is labeling. Things like government and industry regulation, customer responsiveness, operational efficiency, varying production volumes, supply chain collaboration and brand protection are forcing companies to take a hard look at the systems and …

 

Ken Moir Discusses Standardizing Labeling for the Modern Supply Chain

NiceLabel Team Interview Leave a Comment

This post was originally published at the SAPinsder website. Ken Moir, VP of Marketing at NiceLabel, joins the SAPinsider Studio at the SCM, CRM, and IoT 2016 event in Las Vegas to talk about labeling challenges and how NiceLabel and SAP work together to deliver a standardized labeling and marking process that mitigates risk and increases agility. Here is an edited …