The All-in-One 510(k) Data Platform
Accelerate FDA clearance with AI-powered search, comparison, and post-market insights. From predicate selection to safety monitoring, RegHero puts the entire 510(k) and De Novo device landscape at your fingertips.
The All-in-One 510(k) Data Platform
Accelerate FDA clearance with AI-powered search, comparison, and post-market insights. From predicate selection to safety monitoring, RegHero puts the entire 510(k) and De Novo device landscape at your fingertips.
The All-in-One 510(k) Data Platform
Accelerate FDA clearance with AI-powered search, comparison, and post-market insights. From predicate selection to safety monitoring, RegHero puts the entire 510(k) and De Novo device landscape at your fingertips.
Trusted by 20+ MedTech Teams Worldwide
Trusted by 20+ MedTech Teams Worldwide
Trusted by 20+ MedTech Teams Worldwide
Device Search
Search for devices by description
Our machine learning technology understands medical device functionality to find the strongest predicates for your 510(k) submission.
Natural language search
Simply describe your device as you would to a colleague. Our AI understands intended use and technical characteristics.
Intelligent comparison
Review standardized data from each potential predicate to quickly identify which offers the strongest foundation for your submission.
Submission insights
Generate regulatory documentation with properly formatted references to streamline your 510(k) preparation.
Device Search
Search for devices by description
Our machine learning technology understands medical device functionality to find the strongest predicates for your 510(k) submission.
Natural language search
Simply describe your device as you would to a colleague. Our AI understands intended use and technical characteristics.
Intelligent comparison
Review standardized data from each potential predicate to quickly identify which offers the strongest foundation for your submission.
Submission insights
Generate regulatory documentation with properly formatted references to streamline your 510(k) preparation.
Device Search
Search for devices by description
Natural language search
Simply describe your device as you would to a colleague. Our AI understands intended use and technical characteristics.
Intelligent comparison
Review standardized data from each potential predicate to quickly identify which offers the strongest foundation for your submission.
Submission insights
Generate regulatory documentation with properly formatted references to streamline your 510(k) preparation.
CUSTOMER SUCCESS
What our customers say
Join forward-thinking regulatory professionals who are accelerating submissions and strengthening their strategies
Vital for predicate research
RegHero weaves through information and streamlines the search process, enabling faster identification of ideal predicates and allowing us to focus on strategic regulatory decisions.
Plamena Entcheva-Dimitrov, PhD, RAC
Founder, Preferred Regulatory Consulting
CUSTOMER SUCCESS
What our customers say
Join forward-thinking regulatory professionals who are accelerating submissions and strengthening their strategies
Vital for predicate research
RegHero weaves through information and streamlines the search process, enabling faster identification of ideal predicates and allowing us to focus on strategic regulatory decisions.
Plamena Entcheva-Dimitrov, PhD, RAC
Founder, Preferred Regulatory Consulting
CUSTOMER SUCCESS
What our customers say
Vital for predicate research
RegHero weaves through information and streamlines the search process, enabling faster identification of ideal predicates and allowing us to focus on strategic regulatory decisions.
Plamena Entcheva-Dimitrov, PhD, RAC
Founder, Preferred Regulatory Consulting
Why RegHero
All-in-one 510(k) Data Platform
RegHero saves MedTech teams time while ensuring devices remain safe and effective throughout their lifecycle.
75%
Reduction in predicate search time
80%
reduction in manual review
170k+
FDA-cleared devices indexed
3×
faster submission preparation
Why RegHero
All-in-one 510(k) Data Platform
RegHero saves MedTech teams time while ensuring devices remain safe and effective throughout their lifecycle.
75%
Reduction in predicate search time
80%
reduction in manual review
170k+
FDA-cleared devices indexed
3×
faster submission preparation
Why RegHero
All-in-one 510(k) Data Platform
75%
Reduction in predicate search time
80%
reduction in manual review
170k+
FDA-cleared devices indexed
3×
faster submission preparation
PRICING
Try RegHero Today
Pre-Market Essentials
For individual consultants & early startups
$99
/month
Full Access to AI-powered searches
Device Comparison
CSV Exports
PRICING
Try RegHero Today
Pre-Market Essentials
For individual consultants & early startups
$99
/month
Full Access to AI-powered searches
Device Comparison
CSV Exports
PRICING
Try RegHero Today
Pre-Market Essentials
For individual consultants & early startups
$99
/month
Full Access to AI-powered searches
Device Comparison
CSV Exports
© 2025, RegHero Inc.
© 2025, RegHero Inc.
© 2025, RegHero Inc.