Reference project

Improvement of patient safety through UDI Implementation

EXCO is assigned to validate and test a Unique Device Indentification (UDI) database.


Implementation

EXCO supports the development and implementation of a software solution through an established project management method. Thus, documentation for validation and project steering have been delivered in time.


Our clients place trust in the reliability of our software solution and correctness of the documentation. Without this it would not be possible to deliver the data directly into the global FDA database.

Thomas Mengele, Project Manager System Validation Quality & Compliance

Technologies used

The solution is based on the SAP Master Data Governance modul.


Customer benefits
  • Client fulfills the requirements of a FDA audit.
  • Client can continue to offer the medical device in the United States.

Client

Manufacturer of medical devices and diagnostic equipment, Germany

Expert contact

Thomas Mengele

T+49 6233 73778-100