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 […]
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 […]
FDA announced this week a list of more than 1,000 medical devices that will now be exempt from 510(k) notification requirements — a move that aims to help speed up the process of bringing new medical devices to market. The decision was made this week in accordance with a process laid out by the 21st […]
Oracle’s Security Operations Center (SOC) launched 6 months ago and has already surpassed 1 million users. Pragmatyxs has placed a priority on Cloud services to extend and enhance our solutions and have been beyond satisfied with Oracle’s products, business plan and look forward to continue working with them in the future. To read the full […]