medical device and labeling and compliance

Addressing Medical Device Labeling & Compliance Challenges

Susan Gosnell Life sciences, Medical Devices Leave a Comment

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 …

pharmaceutical manufacturers

Overcoming the challenge of accurate supplier labeling

Ken Moir Cloud computing, Life sciences, Pharmaceutical Leave a Comment

Mergers and acquisitions are all too common for pharmaceutical manufacturers. While the combination of two companies has its benefits, it doesn’t come without growing pains and challenges. Take for example, labeling. A merger can result in decentralized labeling processes with inherited home-grown systems and a new array of third-party suppliers, contract manufacturers, re-packagers and re-labelers. It can also lead to …

EU MDR

Five steps to EU MDR-compliant labeling

Susan Gosnell Life sciences, Medical Devices Leave a Comment

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 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 …

boehringer ingelheim

Boehringer Ingelheim creates global, standardized labeling process

Ken Moir Life sciences, Pharmaceutical 1 Comment

“Without having a standard solution, it made it pretty difficult to control, or to have an overview of all the technologies and labels that were used and printed at our different production lines. We had a lot of different label templates and different solutions for printing labels.” This is how Pierre Rahm, IT Operations Services in Boehringer Ingelheim described the …

pharmaceutical supply chain

Driving efficiencies across the pharmaceutical supply chain: How centralized label management can play a key role

Ken Moir Life sciences, Pharmaceutical Leave a Comment

We are seeing pharmaceutical supply chains digitizing across the world. It is a process that involves the implementation of AI, big data analytics, large-scale automation, digital twins and a plethora of other technological advancements that are helping to revolutionize the whole industry by breaking down siloed processes, departments and facilities. Yet despite all the focus on digitization, many companies have …

Talking label best practices for regulated companies

Mari Waldron Life sciences, Pharmaceutical Leave a Comment

On September 25, 2019, NiceLabel hosted an event at Medicon Valley Alliance in Copenhagen, Denmark. The day’s theme was best practice in label management: from solution selection and implementation, to integration and process improvement. The presenters shared their knowledge and experience in how to best handle labeling in a regulated environment. Chr. Hansen shares their label transformation journey The first …