Below you'll find a list of all posts that have been categorized as “Life sciences”
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 …
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 …
“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 …
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 …
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 …
