FDA Data at your fingertips with MDRs, Warning Letters, Recalls and FAERs

Our cleaned, correlated and enhanced data lake makes competitive research, literature review and regulatory reports much faster for Medical Device companies.

MDREngine Data Warehouse

Are you tired searching through MAUDE to find the data you need?  Are you struggling to link Warning Letters with Recalls and Adverse Events?

MDREngine saves Medical Device Companies hundreds of hours per year in data collection and analysis time.

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Why choose us?

100% secure

Built on Salesforce Platform with Encryption on Transit and at Rest

Any device access

Use Smarteeva from anywhere, on any device

Industry leading

Advanced features including machine learning and smart audit trail

Get the most out of our top-notch products

Explore our guides, whitepapers, data sheets, and case studies that help medical device companies scale new heights


Charting the Course: Product Registration Tracking for Medical Devices 


Smarteeva announces the release of the Smarteeva Platform for the Medical Device Industry


Smarteeva Platform Data Sheet

Optimize your adverse event management process

Tired of spending hours on manual data entry and paperwork for adverse event reporting? We’re here to help!