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 …
“The fact that we could have labeling in the Cloud gave us a lot more flexibility in terms of integrations and APIs. When you’re integrating with many sources, this is the better way. Maintenance and software updates are just handled, it’s a lot easier to manage and is more cost-effective.” That’s how Daniel Mycock, IT Manager at IAE summed up …
It’s been a hectic year for food and beverage industry labeling. Several brands have issued mislabeled allergen-based food, and while labeling should be helpful instead of a barrier to consumer safety and speed to market, it clearly has problems. One culprit in the current labeling crisis is outdated labeling processes, which are all too common. Some of these methods include …
Disrupted supply chains, shuttered operations and remote working: the ongoing pandemic has had a significant impact on businesses across the world. Pharmaceutical manufacturers, in particular, find themselves facing an array of new challenges amidst these unprecedented circumstances. Pharmaceutical suppliers have to ensure life-saving medications are safely and rapidly available to those in need, while complying with local restrictions and taking …
Online shopping continues to skyrocket in popularity during the pandemic. While the volatility of our current environment makes it difficult to predict long-term trends, evidence suggests we can expect ecommerce to keep increasing year-over-year across the globe. But this growing opportunity also presents many unique challenges. Due to the additional pressure ecommerce brings to maintain efficiency, it’s vital that supply …
The pharmaceutical industry is one of the most regulated industries in the world. There seems to be no end to the requirements pharmaceutical manufacturers have to comply with, and with good reason. Regulations help ensure the safety and efficacy of medications that millions depend on every day. Relatively new requirements, such as serialization, help to address the growing counterfeit drug …
Supplier compliance is key for organizations to ensure their good keeps moving through the warehouse quickly. It also helps avoid delays caused by labeling errors. But rather than forcing compliance and putting at risk the positive relationships that are crucial to successful supplier management, businesses can and should adopt a standardized process that offers another way forward. In this article, we look …
Many businesses use SAP as their enterprise resource planning (ERP) system. It helps them digitally transform internal processes and brings efficiency gains. Yet, when it comes to managing their labeling operations under SAP, many businesses still struggle. Those using SAPscript or Smart Forms to create labels face a lengthy process for label change requests. This can be a drain on …
On a global scale, Covid-19 and the resulting lockdowns have been challenging for individuals’ mental health. It seems that in one way or another, people may be feeling some strain associated with the crisis. A recent article by The Health Foundation, found that social isolation, job and financial losses, housing insecurity and quality, working in a front-line service, loss of …
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 …
