Medical Device Manufacturers

The Top Four Labeling Challenges Facing Medical Device Manufacturers – And How To Address Them

Susan Gosnell Life sciences, Medical Devices

The medical device market has been growing at a compound annual growth rate of five percent and with an aging population, the COVID-19 pandemic, and the prevalence of chronic disease, it’s showing no signs of slowing. It’s a challenging time for medical device manufacturers. They are forced to balance demands for quality and compliance with operational efficiency – at times …

Prisym ID

Loftware’s Acquisition of PRISYM ID: Uniting the Best Talent in Medical Device and Pharmaceutical Labeling

NiceLabel Team Life sciences, Medical Devices, Pharmaceutical

To find out more about the benefits this recent acquisition provides to customers in the medical device, clinical trials, and pharmaceutical labeling space make sure you register for our upcoming webinar on January 25th at 10AM ET/4PM CET. We’re pleased to today announce that PRISYM ID, a leading provider of regulated content and label management solutions with a focus on …

validation

How Pharmaceutical Manufacturers Can Ease Labeling System Validation

Susan Gosnell Life sciences, Medical Devices, Pharmaceutical

Imagine investing fifteen years or more in developing a promising new drug, only to have a simple labeling error derail your launch plans, or – even worse – result in a product being quarantined or recalled from the market. Unfortunately, this is not at all uncommon. FDA drug recalls are on the rise, increasing 65% over the last decade(Source: GS1), …

Label Cloud Compliance

Easing compliant cloud labeling for regulated companies

Susan Gosnell Cloud computing, Life sciences

Digital transformation has taken the world by storm. An increasing number of companies are adopting cloud-first strategies with pandemic-driven remote work accelerating this transition. However, this step toward modernization comes with some challenges for regulated companies. The myriad of labeling guidelines, along with the requirements and regulations that life sciences companies face can be overwhelming. What’s more, they’re constantly changing …

medical device and labeling and compliance

Addressing Medical Device Labeling & Compliance Challenges

Susan Gosnell Life sciences, Medical Devices

The medical device industry is poised for growth in the coming years. This presents opportunities for many, but also immense challenges and greater strain on the supply chain. And considering that the medical device industry is highly regulated, these companies also have to pay special attention to varying requirements across borders, lengthy approval processes and non-compliance penalties – all of …

EU MDR

Five steps to EU MDR-compliant labeling

Susan Gosnell Life sciences, Medical Devices

The EU MDR one-year delay gives you the opportunity to take a more measured, strategic approach to compliance. However, it’s important to use the time wisely. In this blog, we highlight five steps that will help you on the road to UDI compliance. We’ll also talk about how to review your existing labeling processes and ensure you’re using the best …

EU MDR

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

Susan Gosnell Cloud computing, Life sciences, Medical Devices

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

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

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 …

medical device labeling

Medical device community shares insight on label management tools

Susan Gosnell Medical Devices

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 …