Tuesday Jun 03, 2014

Hologic Ensures Regulatory Compliance & UDI with Agile PLM for the Medical Device Industry

Hologic Logo

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!

About

Hear from the community that's pioneering PLM's critical role in transforming supply chains into sustainable value chains that power profitable innovation and competitive advantage.

Subscribe to Oracle Agile PLM Blog by Email

Search

Archives
« February 2015
SunMonTueWedThuFriSat
2
3
4
5
6
7
8
9
10
11
12
14
15
16
17
18
19
20
21
22
24
26
27
28
       
       
Today