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What is The Difference Between Complex Systems and Convenience Kits?

A convenience kit is one or more devices put together for the convenience of the user. An example of a convenience kit would be a suture removal kit. The FDA has published draft guidance that further clarifies the definition of convenience kit to limit it to those situations where everything is kept together. A configurable system is multiple devices that come together to create multiple pieces of a system that come together to create a finished product. A configurable system, has one or more available components or subsystems that a user can choose. The components come together at the point of installation to create the finished device. The convenience kit has a group of already finished devices that come together to create yet a different finished device, a configurable system is a finished device, so there are various ways to assign UDI to configurable systems, understanding both the intent and the letter of the UDI rule.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM's assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.