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

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

faster submission preparation

Why RegHero

Search + Workflows = Efficiency
75%

Reduction in predicate search time

40%

More relevant predicates discovered

170k+

FDA-cleared devices indexed

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