Accelerate FDA clearances with confidence
RegHero’s 510(k) Copilot™ automates predicate research and submission workflows so you can safely bring new devices to market faster
Accelerate FDA clearances with confidence
RegHero’s 510(k) Copilot™ automates predicate research and submission workflows so you can safely bring new devices to market faster
Accelerate FDA clearances with confidence
RegHero’s 510(k) Copilot™ automates predicate research and submission workflows so you can safely bring new devices to market faster
Empowering the MedTech ecosystem
Empowering the MedTech ecosystem
Empowering the MedTech ecosystem
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.
510(k) Copilot™
Automate regulatory workflows
510(k) Copilot is an AI-powered workflow tool designed to help regulatory affairs (RA) teams draft, validate, and maintain FDA 510(k) submissions faster and with higher first-pass success.
Indications-for-Use Builder
5-question wizard → auto-generates FDA Form 3881 text + XML
510(k) Template Bank
Schema-driven stubs for every eSTAR question + pre-approved boilerplate blocks.
RTA Pre-flight Validator
Runs the same 56-item RTA checklist plus 150 eSTAR business-rules on every save
510(k) Copilot™
Automate regulatory workflows
510(k) Copilot is an AI-powered workflow tool designed to help regulatory affairs (RA) teams draft, validate, and maintain FDA 510(k) submissions faster and with higher first-pass success.
Indications-for-Use Builder
5-question wizard → auto-generates FDA Form 3881 text + XML
510(k) Template Bank
Schema-driven stubs for every eSTAR question + pre-approved boilerplate blocks.
RTA Pre-flight Validator
Runs the same 56-item RTA checklist plus 150 eSTAR business-rules on every save
510(k) Copilot™
Automate regulatory workflows
Indications-for-Use Builder
5-question wizard → auto-generates FDA Form 3881 text + XML
510(k) Template Bank
Schema-driven stubs for every eSTAR question + pre-approved boilerplate blocks.
RTA Pre-flight Validator
Runs the same 56-item RTA checklist plus 150 eSTAR business-rules on every save
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
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
PRICING
Try RegHero Today
No credit card required for free plan
Copilot Free Starter
Essential search for individuals.
$0
/month
10 AI-powered searches
CSV exports
Copilot Essentials
Complete solution for regulatory teams
$99
/month
100 Monthly AI-powered searches
CSV exports
Enterprise plan
Custom solution for MedTech companies and CROs.
Custom
/month
Full 510(k) Copilot Features
Data integrations
Private workspace
PRICING
Try RegHero Today
No credit card required for free plan
Copilot Free Starter
Essential search for individuals.
$0
/month
10 AI-powered searches
CSV exports
Copilot Essentials
Complete solution for regulatory teams
$99
/month
100 Monthly AI-powered searches
CSV exports
Enterprise plan
Custom solution for MedTech companies and CROs.
Custom
/month
Full 510(k) Copilot Features
Data integrations
Private workspace
PRICING
Try RegHero Today
No credit card required for free plan
Copilot Free Starter
Essential search for individuals.
$0
/month
10 AI-powered searches
CSV exports
Copilot Essentials
Complete solution for regulatory teams
$99
/month
100 Monthly AI-powered searches
CSV exports
Enterprise plan
Custom solution for MedTech companies and CROs.
Custom
/month
Full 510(k) Copilot Features
Data integrations
Private workspace
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.