When it comes to making labeling work across global supply chains, many organizations have tried to meet their evolving needs through a variety of homegrown custom solutions. Such solutions may provide steps in the right direction, but they don’t get the job done adequately. These solutions can work to solve immediate challenges but are not […]
Here are some examples of the requirements for labeling in Food & Beverage Examples: The FDA’s Food Safety and Modernization Act (FSMA), aimed at preventing food contamination across every step of the supply chain, including use of imports and exports across international boundaries. FSMA also gives the FDA authority to order a mandatory recall of […]
With 2017 coming to an end, it is a good time to preview what is upcoming in 2018 for medical device labeling in the US. The Unique Device Identification Rule has been a popular topic over the past two years and it has achieved many milestones, requiring medical device manufacturers to follow labeling on Class […]
The European Commission legislation is introducing new compliance requirements on medical devices and creating completely new medical device regulations (MDR). Following in the footsteps of the Food and Drug administration of the US, EU has decided to adopt the Unique Device Identifier (UDI) for all medical devices and In Vitro Diagnostics (IVDR). This will be […]
Pragmatyxs is proactively looking to find solutions that will simplify your companies labeling needs. As product labeling continues to evolve we at Pragmatyxs believe Software as a Service (SaaS) is the latest and greatest solution to help your company be more cost effective, efficient and supportable. Below you will find the advantages to SaaS in […]
UDI requirements for class 3 and class 2 devices are now behind you, but the compliance standards continue to emerge and you must maintain the ones you have already completed. Maybe your organization is impacted by all three (3) UDI class distinctions, or MDR (European UDI) standards, or you have additional requirements to maintain these […]
Several dates for UDI compliance have been postponed: • Class I and unclassified devices – 24th of September, 2020 • Direct Marking of Class I and unclassified devices – 24th of September 2022 Low-risk devices are required to follow the UDI ruling two years later than it was originally planned (24th of September 2018). Class […]
The Pragmatyxs family would like to send our sincerest condolences to Puerto Rico during these tough times and offer our hand in assisting in any way possible. Please know you are not in this fight alone. If your business or personal matters have been affected by these natural disasters please reach out to Pragmatyxs […]