Smart Predicate
Search for your best 510(k) predicate
Cut hours of manual research. Let Smart Predicate surface the strongest matches for your submission with speed and precision.
Smart Predicate
Search for your best 510(k) predicate
Cut hours of manual research. Let Smart Predicate surface the strongest matches for your submission with speed and precision.
Smart Predicate
Search for your best 510(k) predicate
Cut hours of manual research. Let Smart Predicate surface the strongest matches for your submission with speed and precision.
Why Smart Predicate?
Designed for regulatory teams, Smart Predicate bridges the gap between unstructured FDA data and confident decision-making.
Smart Match
Describe your device's indications of use and technical characteristics naturally. Receive predicate matches based on functionality, not just keywords.
Side-by-Side Comparison
Evaluate potential predicates with standardized data to quickly identify your strongest options for submission.
Landscape Analytics
Visualize the device landscape to understand market positioning and identify strategic opportunities.
Export & Documentation
Generate share-ready reports with properly formatted references to streamline the preparation of regulatory documentation.
Time-Saving Automation
Replace days of manual database searches with minutes of intelligent matching, reducing predicate search time by up to 75%.
Why Smart Predicate?
Smart Match
Describe your device's indications of use and technical characteristics naturally. Receive predicate matches based on functionality, not just keywords.
Side-by-Side Comparison
Evaluate potential predicates with standardized data to quickly identify your strongest options for submission.
Landscape Analytics
Visualize the device landscape to understand market positioning and identify strategic opportunities.
Export & Documentation
Generate share-ready reports with properly formatted references to streamline the preparation of regulatory documentation.
Time-Saving Automation
Replace days of manual database searches with minutes of intelligent matching, reducing predicate search time by up to 75%.
Why Smart Predicate?
Designed for regulatory teams, Smart Predicate bridges the gap between unstructured FDA data and confident decision-making.
Smart Match
Describe your device's indications of use and technical characteristics naturally. Receive predicate matches based on functionality, not just keywords.
Side-by-Side Comparison
Evaluate potential predicates with standardized data to quickly identify your strongest options for submission.
Landscape Analytics
Visualize the device landscape to understand market positioning and identify strategic opportunities.
Export & Documentation
Generate share-ready reports with properly formatted references to streamline the preparation of regulatory documentation.
Time-Saving Automation
Replace days of manual database searches with minutes of intelligent matching, reducing predicate search time by up to 75%.
© 2025, RegHero Inc.
© 2025, RegHero Inc.
© 2025, RegHero Inc.