MDM Solution: Global Item Governance with UDI

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Highlights

Mastech InfoTrellis enabled the client to submit 32,000+ device records to the FDA within three weeks

The MDM solution simplifies regulatory and labeling data management through BPM, ensuring FDA compliance

By reducing manual efforts for product release and FDA registration, the solution boosts productivity and accelerates time to market

Overview

Two medical device manufacturing leaders merged, demanding global governance and efficient FDA compliance. Mastech InfoTrellis swiftly crafted an MDM and UDI solution to consolidate product data, establish a single data source, and streamline device identification.

Client

Leading Medical Device Manufacturers

Geography

Global

Industry

Medical Device Manufacturing

Tech Stack

MDM and UDI solutions

The Challenges

The client faced tight FDA deadlines to submit Regulatory and Labeling data for Class 2 items, with potential repercussions for unregistered items and additional FDA fines
The lack of a pre-built UDI solution hindered effective device data management and record-keeping
Managing correctness and governance of extensive medical device data became complex following a merger