Serialization/Unique Device Identification

Many of FDA’s Unique Device Identification requirements have already phased in. The labels and packages of Class III and Class II medical devices, for instance, must now bear a UDI.“But UDI is not over,” says Ardi Batmanghelidj, President and CEO...

Johnson & Johnson Supply Chain (JJSC) and AmerisourceBergen Corporation (ABC) recently collaborated on a pilot study on implementing GS1 traceability standards. PMP News asked Mike Rose, Vice President of Supply Chain Visibility, and Chris Reed...

As medical device companies work to ensure compliance with Unique Device Identification, they’re still dealing with on-going tasks such as ensuring package integrity. A vision solutions provider believes it can take on both tasks. At WestPack 2017...

To help medical device manufacturers meet Unique Device Identification (UDI) rules as well as satisfy other marking needs, RTP Company has introduced laser-markable thermoplastic compounds. The materials can be used for packaging as well as for...

As 2017 deadlines for pharmaceutical serialization draw near, Steve Wood, president of Covectra (www.covectra.com), has seen an increase in activity. “The large pharmaceutical companies decided years ago to get started, but some smaller companies...

September 2016 brings several key deadlines for Unique Device Identification (UDI), a system of medical device identification rules issued by FDA in 2013. UDI requirements state that the device labeler, in most cases the manufacturer, must include...