Hologic Ensures Regulatory Compliance & UDI with Agile PLM for the Medical Device Industry
By Ulf Koester-Oracle on Jun 03, 2014
A new success story featuring Hologic, Inc., is now available. Hologic is known for developing innovative medical technology—like the world’s first 3-D mammogram—that can quickly diagnose women’s health issues and save lives in the process.
The success story features Hologic’s use of Oracle Agile PLM to ensure regulatory compliance in every phase of product development, including managing all product-related data, design history files, and device master records. Hologic is using Oracle Agile PLM as the foundation for Unique Device Identification (UDI). Thanks to Agile PLM, Hologic can easily interface with the FDA’s database (GUDID) to streamline compliance, without devoting additional time and resources towards a new solution.
Hologic is one of the first 2 companies granted production accounts by the FDA for GUDID submittal, and is the first company to submit official data. This an important milestone for Oracle Agile PLM, our partner Inspirage and the Medical Device industry as a whole.
Read the full story here!