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 …

food safety

Food labeling in the midst of a pandemic: Addressing the need for safety without compromising speed to market

Ken Moir Food and beverage Leave a Comment

The COVID-19 pandemic has changed business as we know it in so many ways. In the food industry for example, manufacturers, restaurants and retailers have had to rapidly shift how they supply food to consumers. Changes have been implemented in the interest of safety, but the result has been supply chain bottlenecks that cause delays in getting food to it’s …

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 …

supplier labeling

Mastering compliance with cloud-based supplier labeling

Ken Moir Cloud computing Leave a Comment

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 …

supplier labeling

Five common challenges to supplier labeling – and how to solve them

Mari Waldron Cloud computing, Industry news Leave a Comment

In working with our customers to digitally transform their labeling, we see firsthand the challenges they face when trying to extend their standardized, digitally-transformed labeling process to their suppliers.  Here are the five most common challenges we see (and how we solve them): Challenge #1: Suppliers often have vastly different IT infrastructures and varying levels of technical knowledge. Their IT …

label management in manufacturing

Streamlining label management in the manufacturing sector

Ken Moir Industry news Leave a Comment

Unsurprisingly, labeling is not a subject which is often focused upon in the busy world of manufacturing. Yes, it’s seen as important, but there are myriad other factors that shape success in the industry. As a result, many organizations’ have disparate or legacy systems which are a huge burden on IT. For instance, it is common for each distribution center, …

Medical device

European Medical Device Directives – How a small-medium sized medical device company responded to the new regulations

Susan Gosnell Medical Devices Leave a Comment

The medical device directives are currently being revised by the EU’s institutions in a process that began in 2008. This revision has the following objectives: To ensure a consistently high level of health and safety protection for EU citizens using these products To maintain the free and fair trade of the products throughout the EU To adapt legislation to the …

Helpful resource in planning for September UDI deadline for Class II device compliance

Susan Gosnell Medical Devices Leave a Comment

Manufacturers of Class II medical devices must comply with the FDA’s Unique Device Identifier (UDI) regulations by September 2016, the latest in a series of deadlines for varying devices. Are you ready? The FDA manages a Global Unique Device Identifier Database (GUDID), to which manufacturers must submit their device details, via one of three accredited agencies. There is a fair …

Who bears responsibility for submitting UDI data to the GUDID

Who bears responsibility for submitting UDI data to the GUDID?

Reed Tech Medical Devices Leave a Comment

The FDA has specified in its Final Rule on Unique Device Identification (UDI) that medical device labelers marketing their products in the United States are required to submit data records to its Global Unique Device Identifier Database (GUDID, pronounced “Good-ID”). Which company qualifies as the device labeler? The next question to ask is which company (or companies) involved in bringing …