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.
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.
Clean Data
Our team has build proprietary algorithms to link, clean and enhance data from MDRs (MAUDE) with Warning Letters, Recalls, Product Registrations and FAERS.
Blazing fast performance
Our technology and data science investments have helped us deliver the fastest user interface performance possible for an application of this magnitude.
Automatically and Continually Refreshed
Our data engineers pick up and refresh data from FDA services the moment they become available.
Access all relevant information in one place
We integrate our adverse event management and reporting system with the complaints management system, allowing you to spend less time searching for data, and more time focused on taking action.
Track all changes in adverse event records with ease and efficiency
Our system tracks all the meaningful data changes across related adverse event records. You'll be able to easily see what information has changed during investigations or complaints directly from the complaints screen.
Generate regulatory reports effortlessly with custom reports
We offer the ability to create XML and PDF reports for regulatory agencies, including EUMDR, MDR, Canada, and more. And if you need additional reports, we can create them for you.
Stay up-to-date with crucial regulatory codes
All MDR and EUMDR codes are included in our system, and we update them every time the regulatory agencies send changes or additions.
Streamline data entry and focus on crafting the perfect message
Our system allows you to manage reusable data such as manufacturer information, reporter information, or importer information separately. This means less time spent on data entry, and more time spent crafting the perfect message to regulators.
Optimize data entry with smart decision trees
Our sophisticated decision trees make it easy to manage decisions about report type, due date, and other critical information. This leads to more efficient data entry and a more streamlined process overall.
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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
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!
