Stories of our customer success
Discover our repository of case studies that showcase real-world examples of how we are modernizing data for customers.
Streamlined FDA Submission: 32K+ Device Records in Three Weeks
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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 Digital 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