Smart Predicate
Find 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
Find 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
Find 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%.
Why RegHero
Search + Workflows = Efficiency
RegHero doesn't just improve search — it transforms workflows and saves teams hours per submission.
75%
Reduction in predicate search time
40%
More relevant predicates discovered
170k+
FDA-cleared devices indexed
4×
faster submission preparation
Why RegHero
Search + Workflows = Efficiency
75%
Reduction in predicate search time
40%
More relevant predicates discovered
170k+
FDA-cleared devices indexed
4×
faster submission preparation
Why RegHero
Search + Workflows = Efficiency
RegHero doesn't just improve search — it transforms workflows and saves teams hours per submission.
75%
Reduction in predicate search time
40%
More relevant predicates discovered
170k+
FDA-cleared devices indexed
4×
faster submission preparation
Try Smart Predicate Today — Free
Experience smarter predicate search today. No credit card required.
Try Smart Predicate Today — Free
Experience smarter predicate search today. No credit card required.
Try Smart Predicate Today — Free
Experience smarter predicate search today. No credit card required.
Whether you're launching a new medical device or supporting a client submission, RegHero handles the regulatory heavy lifting — fast, accurate, and AI-powered.
Whether you're launching a new medical device or supporting a client submission, RegHero handles the regulatory heavy lifting — fast, accurate, and AI-powered.
Whether you're launching a new medical device or supporting a client submission, RegHero handles the regulatory heavy lifting — fast, accurate, and AI-powered.