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5 Things to Consider When Defining Your UDI Strategy

The FDA has passed legislation requiring all medical devices to have a unique device identification (UDI) number to make them recognizable and traceable across the entire medical field. By 2020, all medical devices must have labels containing the UDI, which is readable by both humans and machines. The information about each device then has to be submitted to the FDA’s Global Unique Device Identification Database (GUDID).


If you are in the medical field, therefore, you are going to need to make some adjustments to be compliant with these new regulations.


Why UDI with Southeast Computer Solutions?
Hear from Abraham Farhan.

Defining a UDI Strategy

Before you can outline a UDI strategy, though, you must understand your business's current product data structure and identify gaps in your current processes; you should also focus on the cleanliness, totality, and standardization of your product's master data. Only after you’ve accomplished these tasks can you map a new environment specific to the UDI requirements.


The first step is choosing a system to record your product's UDI data. The system serves as a hub for all product data and will share master UDI data with external systems, including the FDA GUDID and the GS1/GDSN data pools.

What to Ask Yourself

Consider these questions as you analyze your current product data management system and consider your UDI implementation strategy:


The FDA offers 3 methods to update the GUDID, including:

Answering those questions and considering those methods will drive any strategic decisions you make regarding a data management system and your overall UDI implementation strategy, with the end goal being UDI compliance.


For more information about implementing a UDI system, contact Southeast Computer Solutions today.

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About Southeast Computer Solutions

Southeast Computer Solutions is based in Miami, Florida, and has additional operations in Mexico. For over 30 years, we have positively impacted the success of small and mid-sized businesses with effective business management implementations that improve our clients’ operations. We listen, we are accessible, and we care. Learn more by visiting our website or calling 305-556-4697.


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