To remain FDA compliant, all medical devices must have labels that contain a unique device identification (UDI) – a number that makes them recognizable and traceable across the entire medical field – by 2020. The UDI, readable by both humans and machines, offers the opportunity for global transparency in the medical field.
Businesses in the medical field, of course, will have to take steps to ensure their compliance with this evolving FDA standard.
In our previous blog, 5 Things to Consider When Defining Your UDI Implementation Strategy, we discussed several ways to start planning a UDI strategy unique to your business. In short, it said that you can’t outline a UDI strategy without first understanding your business’s current product data structure and identifying gaps in processes.
When delving into creating and implementing a UDI strategy with a more architectural approach, most businesses quickly realize several key issues during their initial analysis phase, including:
But there’s an enterprise resource planning (ERP) system that can help – Sage Enterprise Management (Sage X3). Southeast Computer Solutions helps their clients implement Sage Enterprise Management, allowing their clients to meet industry and organizational requirements by creating user roles and preferences to deliver simple, easy-to-use software on any web browser or mobile device. The UDI project management team at Southeast Computer Solutions have years of development and implementation experience and will deliver a solution tailored to your needs.
Why UDI with Southeast Computer Solutions? Hear from Abraham Farhan.
The Sage Enterprise Management platform also provides the following features to help facilitate industry compliance and standardizations while creating a UDI implementation:
The medical device industry is one of the most competitive and highly regulated industries in the world, making it critical to have a data management system. Let the experts at Southeast Computer Solutions help you optimize your processes, maintain regulatory compliance, and sustain your competitive advantage.