Medical Device Labeling

Managing regulatory labeling challenges in the medical device sector

Ken Moir Medical Devices Leave a Comment

A unique device identification (UDI) system for medical devices is essential in identifying them wherever they are in the healthcare supply chain. In fact, the United States Food and Drug Administration (FDA), the European Commission and other regulators have made patient safety a strategic priority by developing legislation for UDI. And in addition, manufacturers also need to comply with the …

UDI compliance

UDI Conference Recap – Getting Labeling Ready for Global Compliance

Susan Gosnell Medical Devices Leave a Comment

Last month, NiceLabel joined members of the FDA and medical device manufacturers from across the country at the 2018 UDI Conference. As with past years, there was a focus on the many benefits of UDI – from reducing medical errors to improving purchasing and supply chain efficiency, however this year there was an added focus on global UDI-related activity. The …

UDI - quality assurance

How UDI compliance can be the key to digitally transforming quality assurance

Susan Gosnell Medical Devices Leave a Comment

2020 is a year etched into the minds of many medical device manufacturers (MDMs). Not only does the United States Food and Drug Administration’s (FDA) UDI compliance date for Class I and non-classified devices fall in that year, it’s also the year the recently approved European medical device regulations (MDR) go into effect. These impending deadlines have MDMs taking a …