This Zebra PAX4 End of Serviceis to inform the reader of this memo that service and support for all Zebra PAX4 models will be discontinued on November 15, 2018. After this date, service and support will no longer be available from Zebra. It is strongly suggested that Zebra PAX4 users migrate to the most recent […]
With manufacturing plant locations and distribution facilities operating globally, companies are seeing the benefits of developing a standardized global labeling approach. Pragmatyxs has been engaged in developing solutions for global label operations for many years. We have consulted with many organizations that have multiple plant locations in migrating from their own custom legacy labeling solutions […]
Much like the experience we have all recently gained in the United States during the deployment of UDI for Class 3 and now Class 2 devices and soon Class 1. The goals of the European Medical Device Regulation (MDR) and In-Vitro Diagnostic Directive (IVDR) are to provide for the safety and well-being of the consumers […]
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 […]
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 […]