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European Commissions (EU) latest revision for UDI

The European Commission (EU) announced its latest revisions to the proposed rule changes for unique device identification (UDI) requirements. The agreement has been in the development stage for the past year and the EU has now developed tighter rules for medical manufactures. These rules center on areas such as trace-ability and are designed to ensure […]


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 […]


Pharmaceutical Growth On Record Pace

The Association for packaging and processing technologies, examined the latest trends impacting the pharmaceutical market. Global sales in 2016 have reached a record high for pharmaceutical sales at $1.1 Trillion, with North America alone generating $574 billion. The greatest influence on growth in the pharmaceutical industry is general economic development. As more people can afford […]


Countdown to the DSCSA 2017 Deadline

  The Drug Supply Chain Security Act – DSCSA (Title II, Drug Quality and Security Act, 2013) has been signed into law, with full implementation phased in over the next 10 years. The next milestone for manufacturers is November 27, 2017; the date by which Pharmaceutical manufacturers are required to print a unique product identification […]


Improving your labeling process to be more efficient.

Companies worldwide are challenged with developing and maintaining efficient disciplined product labeling. They are tasked with a wide range of internal requirements, Marketing and Product Branding and external regulatory requirements, such as GHS or UDI compliance requirements. As example, the chemical industry and their respective supply chains are continuously evolving and have as complex a […]


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!


Quality Assurance with Traceability

Demand for safe packaging to combat illicit drug market rackets spread across the globe is increasing. The present market is plagued by forged pharmaceutical formulas. The soaring market size of counterfeit drugs is creating a parallel economy in the global market. The emerging threat has a rippling effect on all the stakeholders as well as […]


Benefits of a UDI System

When we talk about UDI in our industry, we always refer to the classes, Class 3, Class 2 and Class 1 UDI and we always reference the due dates. What gets lost in this discussion is the actual benefits that accompany UDI. When UDI is fully implemented there are benefits to multiple organizations: the organization […]


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 […]