Enterprise Resource Planning or ERP has been an essential part of many businesses from mid-size companies to large-size corporations. ERP software can integrate all the processes a company needs to successfully run. ERP systems have evolved over time, and most have created a web-based application, enabling users to access it remotely. Unfortunately, this system can […]
The FDA is looking to move to a “New Era of Smarter Food Safety” over the next decade. They believe, as foods are reformulated, new food production methods created and the food system is more digitized, the need for new and modified safety methods must also adapt. The FDA has created a Blueprint, with input […]
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 […]
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 […]
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 […]
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 […]