Contact Support

510(K) Medical Device Exemptions

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 […]


In the News: Oracle Security Cloud Services Expanding

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 […]


Medical Device Audit Preparation

Quality system audit schedules are typically published at the beginning of each year; however, internal auditing personnel may find themselves unprepared when actual audit dates approach. In such instances, companies undertake last minute preparations of checklists and audit questions that generally take months to develop. This can lead to a rushed audit process where corrective […]


Class III Medical Devices; News and Information

The first compliance date for Unique device identification, UDI, class III was September 2014. Class III medical devices are defined as devices that support or sustain human lives, Class III Medical Devices include implanted pacemakers, heart valves and implanted cerebral simulators. At that time the FDA mandated that labels and packages of class III medical […]


Happy Holidays!

The Pragmatyxs team would like to wish you and your family a happy and safe holiday season.  We appreciate your business and look forward to another successful year!


Preparing to Meet UDI Compliance Dates

The healthcare industry has been rapidly preparing for FDA compliance requirements, on all medical devices (Class I-Class III.)— With the FDA’s latest deadline being completed for Class II devices this September, are you prepared for the Class I deadline? With each UDI deadline provide a new challenge for the medical device community. While many companies […]


In The News: Premature Battery Depletion of ICD and CRT-D Devices

The FDA has released a safety communication for patients with a St. Jude Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Defibrillator (CRT-D) device due to batteries failing earlier than expected. These ICD and CRT-D devices are critical to the survival of patients and there have been 2 reported deaths currently due to battery failure.  […]


Latest features in the always evolving PXSmartLabel

Pragmatyxs Smart Label (PXSL) is our answer to simplifying the label printing process; while it is a very intuitive, easy to use tool to the operator it is a product that allows so much more than meets the eye.  Pragmatyxs is constantly reviewing and implementing new features that we feel will improve our customers everyday […]


Pragmatyxs discusses benefits of Oracle Cloud

A great blog post from Oracle (www.Oracle.com) with our CEO Paul Van Hout discussing how vital it was for our business to migrate to the cloud to ensure all ends of our business are reliable and efficient. Read more in the link below: https://blogs.oracle.com/midsize/small-business-big-technology      


Pragmatyxs CEO Speaking at Oracle Open World 2016

Paul Van Hout, Pragmatyxs CEO at Oracle Open World discussing the benefits of Oracle Cloud and how those benefits are utilized by Pragmatyxs.