## FDA Data at Your Fingertips - MDRs, Warning Letters, Recalls, and FAERs

MDREngine aggregates, cleans, correlates, and enhances medical device regulatory data from the FDA and other sources, giving your quality, regulatory, and R&D teams instant access to the intelligence they need.

- **Search MDRs, recalls, and warning letters instantly**
- **Cross-referenced data, not fragmented databases**
- **Always current, never a stale snapshot**

## F D A  d a t a b a s e s  a r e  s p r a w l i n g ,  i n c o n s i s t e n t l y  f o r m a t t e d ,  a n d  d i f f i c u l t  t o  s e a r c h .  D a t a  f r o m  d i f f e r e n t  s o u r c e s  d o e s n ' t  c r o s s - r e f e r e n c e .  B y  t h e  t i m e  y o u ' v e  c o m p i l e d  w h a t  y o u  n e e d ,  h o u r s  o r  d a y s  h a v e  p a s s e d .

## One platform. Every data source. Fully correlated.

### Competitive intelligence
How do your complaint rates compare to industry benchmarks? MDREngine pulls adverse event history across manufacturers and device categories so you always know where you stand.

### Submission support
What adverse event history exists for similar devices? Pull the data you need for regulatory submissions without manually searching MAUDE.

### Product intelligence
What failure modes are being reported in your device category? MDREngine surfaces signals that inform next-generation design decisions.

## What's inside the data lake

### **Medical Device Reports (MDRs)**
The complete database of adverse event reports filed with the FDA, cleaned and enhanced for searchability. Search by device type, manufacturer, event type, patient outcome, and more.

### **FDA Adverse Event Reports (FAERs)**
Adverse event data for drugs and combination products, cross-referenced with device data for companies operating across product categories.

### **Recalls**
FDA recall data including Class I, II, and III recalls, with details on affected products, recall scope, corrective actions, and manufacturer responses.

### **Warning Letters**
FDA warning letters indexed by company, product category, and violation type. Understand enforcement trends and identify common compliance gaps in your product category.

### **Clinical Studies**
Clinical study data relevant to medical devices, providing context for regulatory submissions and post-market surveillance reports.

### **Industry News**
Curated news and regulatory updates affecting the medical device industry, keeping your team informed of developments that could impact your products.

## Use cases

### **Competitive Benchmarking**
How do your adverse event rates compare to similar devices from other manufacturers? MDREngine lets you benchmark your quality data against industry-wide FDA data.

### **PMS Report Support**
PMS reports under EU MDR require companies to consider external data sources. MDREngine provides the literature and regulatory data that supports your PMS report conclusions.

### **Regulatory Submission Preparation**
When preparing 510(k) submissions, PMA supplements, or other filings, MDREngine provides instant access to adverse event history, recall history, and clinical data for predicate and comparable devices.

### **Signal Detection**
Identify emerging safety signals across the industry that could affect your products, before they show up in your own complaint data.

### **Audit Preparation**
When an FDA inspector asks about adverse event trends in your product category, MDREngine gives you the data to contextualize your own quality performance within the broader industry landscape.

## Questions?  We’re glad you asked.

**What data sources does MDREngine aggregate?**
MDREngine aggregates data from FDA databases including MDRs (Medical Device Reports), FAERs (FDA Adverse Event Reports), recall databases, warning letter archives, clinical study registries, and curated industry news sources.

**How is MDREngine data different from searching FDA databases directly?**
MDREngine cleans, correlates, and enhances raw FDA data. Records are cross-referenced across databases, inconsistencies are resolved, and the data is structured for fast, meaningful search and analysis, eliminating the hours of manual data wrangling required when using raw FDA sources.