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Streamlined FDA Submission: 32K+ Device Records in Three Weeks



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

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

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


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. 


Leading Medical Device Manufacturers




Medical Device Manufacturing 

Tech Stack

MDM and UDI solutions

Tags: Data Governance

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