Contact Support

MDR/IVDR

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 […]


UDI Exceptions on Single Use Devices

Last week we discussed the extension the FDA has granted on the Unique Device Identifier (UDI) Class II Mandates. Similar to the extension there are also exceptions on single use devices that medical manufactures should be aware of. The exception states that if you put a (UDI) on the next higher level of packaging you […]


FDA Extends Mandates for Certain Class II Devices

The US Food and Drug Administration (FDA) is extending the deadline to comply with unique device identifier (UDI) requirements for certain Class II devices. The first mandate posted was that all Class II devices must be in compliance by September of 2016. Now, FDA says it is extending the compliance date for certain Class II […]


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 […]


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 […]


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 […]


FDA to kickoff Drug Supply Chain Security Act meeting this month

Counterfeit pharmaceutical drugs is a billion dollar a year industry that has put a dark stain on the healthcare industry as the lack of regulatory standards has put patients lives at risk.  As a result the FDA is trying to reduce and eliminate counterfeit drugs through the DSCSA (Drug Supply Chain Security Act.) Signed by […]