EU MDR

As the EU MDR deadline approaches, seize the opportunity to digitize quality assurance

Susan Gosnell Cloud computing, Life sciences, Medical Devices Leave a Comment

The postponement of the EU MDR deadlines has given medical device manufacturers a unique opportunity to digitize quality assurance as they take steps to comply with MDR requirements. By seizing this opportunity, MDMs can simplify the compliance process, ensure greater label accuracy and, ultimately, get their products to market faster. If you’re facing the EU MDR deadline, the last thing …

medical device webinar

Webinar recap: How to comply with medical device UDI requirements

Susan Gosnell Life sciences, Medical Devices Leave a Comment

FDA Class I just the beginning  There is a wave of regulations hitting medical device manufacturers (MDMs) with international operations. In addition to the upcoming deadlines for US FDA Class I and the EU MDR date of application, the in vitro diagnostic regulation (IVDR) date of application goes into effect in May 2022. After that, there are a number of other application …

Medical Device Labeling

Managing regulatory labeling challenges in the medical device sector

Ken Moir Medical Devices 1 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 …

SKU proliferation

Managing complexity: How to cope with SKU proliferation

Susan Gosnell Medical Devices, Pharmaceutical Leave a Comment

Stock-keeping unit, or SKU, proliferation has been a topic of discussion in just about every industry for the better part of a decade. Food and beverage, apparel and garment, consumer goods – all of these industries have had to cope with the logistical challenges of managing hundreds, or thousands of SKUs. The life sciences industry is no exception. The Healthcare …

medical device labeling

Medical device community shares insight on label management tools

Susan Gosnell Medical Devices 1 Comment

Last week at the Q1 Productions 8th Annual Medical Device & Diagnostic Labeling Conference, delegates from medical device manufacturers, notified bodies, legal firms and solution providers came together to discuss the latest developments in medical device labeling including integration of new labeling requirements like EU MDR / IVDR, achieving UDI barcode quality, direct marking challenges and label creation and delivery …

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 best practice

UDI is going global. Are you ready?

Susan Gosnell Medical Devices Leave a Comment

A recent Emergo blog summarized a workshop held by the European Commission earlier this month where it was revealed that most markets worldwide will have a system for Unique Device Identification (UDI) within the next five years. Based on the presentations by the various medical device authorities, the current thinking is that it will be possible to use a single …

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 …

Medical Device labeling

A recap of the Medical Device Packaging & Labeling Summit

Susan Gosnell Medical Devices 6 Comments

Last week, medical device manufacturers from across the U.S. came together to discuss the constantly changing world of labeling at Q1 Productions’ 6th Semi-Annual Medical Device Packaging and Labeling Summit. While abiding by FDA labeling requirements presents ongoing challenges for these companies, topics like localization and translation also dominated much of the agenda. This group is always candid and open …

The EU MDR and IVDR have been approved. So, what’s next?

Susan Gosnell Medical Devices Leave a Comment

On April 5th Europe finally adopted the MDR and IVDR after a vote at the European Parliament. This was the last step in the European Union’s long process of overhauling medical device and IVD regulation. The new regulations on medical and in-vitro diagnostic medical devices will help to ensure that all medical devices – from heart valves to sticking plasters …