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 […]
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!
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 […]
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. […]
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
Paul Van Hout, Pragmatyxs CEO at Oracle Open World discussing the benefits of Oracle Cloud and how those benefits are utilized by Pragmatyxs. https://youtu.be/G8vt-jcbFVc
We are nearing almost 3 years of the original publication of the UDI final ruling. What this means to medical device manufacturers is that we are just over a month away (September 24, 2016) for certain deadlines around Class III and Class II devices and packaging. Class III regulations due Sept. 24th: UDI required devices […]
Pragmatyxs SmartLabel (PXSL) wasn’t created for just improving print operators user experience on the manufacturing and labeling line. It was also created as a tool that can offer proper validation, record history and security. Pragmatyxs is constantly evolving PXSL to not only meet customer requirements but also to improve processes that organizations haven’t even thought […]