The Unique Device Identification (UDI) System is intended to assign a unique identifier to medical devices within the United States and Europe. It was signed into law on September 27, 2007, as part of the Food and Drug Administration Amendments Act of 2007.
All Medical Device companies need to comply with this in order to create a common vocabulary for reporting and enhance electronic tracking abilities. The UDI System is expected to improve patient safety, facilitate and improve the recall process and create efficiency within the medical system.
Together with Siemens, TimeSeries has created a Smart App Template to fulfill these regulatory requirements quickly and efficiently, while being able to customize and integrate this accordingly. Our UDI Submission Management template allows the connections between a Medical Device company and the FDA for electronic submission management.
Smart App Template
The template helps clients during the initial product launch phases to improve existing manual processes, gain transparency and quality in their UDI submissions and provide a better vantage point to the health of the entire process.
In sum, the template
- Is an application layer that sits on top of your core systems like ERP/PLM.
- Has the ability to tie data back to a regulatory database and acts as the entry into QMS.
- Uses a PLM system, i.e. Siemens Teamcenter, to aggregate the numbers as they come from different places.
- Can develop catalogs from your ERP like SAP.
- Interfaces with government databases.
The UDI Submission Management template offers the ease of off-the-shelf solutions and the flexibility of custom app development. It provides a comprehensive and user friendly application template for companies to adopt with minimal effort in development and integration.