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
AI-powered 510(k) Submission
Search for the best predicate device
Find the best predicate matches in seconds with Smart Predicate
Plan Regulatory Roadmap
Create a clear regulatory roadmap with recommended tests, benchmarks, and applicable FDA standards.
Draft Regulatory Docs
Generate Indications for Use (IFU) drafts with AI that understands regulatory language and FDA requirements.
Validate Submission
Review and validate your submission to reduce RTA risks and ensure compliance.
AI-powered 510(k) Submission
Search for the best predicate device
Find the best predicate matches in seconds with Smart Predicate
Plan Regulatory Roadmap
Create a clear regulatory roadmap with recommended tests, benchmarks, and applicable FDA standards.
Draft Regulatory Docs
Generate Indications for Use (IFU) drafts with AI that understands regulatory language and FDA requirements.
Validate Submission
Review and validate your submission to reduce RTA risks and ensure compliance.
AI-powered 510(k) Submission
Search for the best predicate device
Find the best predicate matches in seconds with Smart Predicate
Plan Regulatory Roadmap
Create a clear regulatory roadmap with recommended tests, benchmarks, and applicable FDA standards.
Draft Regulatory Docs
Generate Indications for Use (IFU) drafts with AI that understands regulatory language and FDA requirements.
Validate Submission
Review and validate your submission to reduce RTA risks and ensure compliance.
CUSTOMER SUCCESS
See 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
See 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
See 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
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
Copilot Essentials
For individual consultants & early startups
$99
/month
100 Monthly AI-powered searches
Device Comparison
CSV exports
Copilot Pro
For teams preparing multiple submissions
$299
/month
Everything in Essential, plus unlimited searches
Roadmap Planner
Document Drafting
Enterprise plan
For CROs and scale-up MedTech orgs
Custom
/month
Full 510(k) Copilot Features
Data integrations
Private workspace
PRICING
Try RegHero Today
Copilot Essentials
For individual consultants & early startups
$99
/month
100 Monthly AI-powered searches
Device Comparison
CSV exports
Copilot Pro
For teams preparing multiple submissions
$299
/month
Everything in Essential, plus unlimited searches
Roadmap Planner
Document Drafting
Enterprise plan
For CROs and scale-up MedTech orgs
Custom
/month
Full 510(k) Copilot Features
Data integrations
Private workspace
PRICING
Try RegHero Today
Copilot Essentials
For individual consultants & early startups
$99
/month
100 Monthly AI-powered searches
Device Comparison
CSV exports
Copilot Pro
For teams preparing multiple submissions
$299
/month
Everything in Essential, plus unlimited searches
Roadmap Planner
Document Drafting
Enterprise plan
For CROs and scale-up MedTech orgs
Custom
/month
Full 510(k) Copilot Features
Data integrations
Private workspace
© 2025, RegHero Inc.
© 2025, RegHero Inc.
© 2025, RegHero Inc.