US FDA data search and analysis platform
for medical device registration management
for medical device registration management
Regulatory affairs managers
use RECLECOM for
use RECLECOM for
Turns a week of work into 30 minutes
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READY WHEN YOU ARE
Personal assistant for regulatory affairs managers
- Comprehensive device classification;
- Discover more relevant predicates;
- Build multiple regulatory pathways;
- Define testing strategy before start;
- Comparative regulatory analytics;
- Tracking project history and downloading data;
- Automatic forms and documents drafting.
So what does that get you?
Before: reading 200-page PDFs
Now: extracted data in minutes
Now: extracted data in minutes
Automatically extracts tests, standards, and key technical data from FDA documents into a structured table.
Data extraction
Before: a full day searching
Now: 5 minutes
Now: 5 minutes
Finds FDA-cleared equivalent devices and their 510(k) submissions based on key product characteristics.
Predicate’s searching
Before: 3 hours browsing
Now: 2 minutes
Now: 2 minutes
Converts a plain-language device description into FDA classification, product code, and regulatory requirements.
Device classification
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