Empowering MedTech, From Pre-Market to Post-Market.
By automating data extraction, reporting, and regulatory workflows, we transform weeks of manual work into secure, actionable insights in minutes.
Empowering MedTech, From Pre-Market to Post-Market.
By automating data extraction, reporting, and regulatory workflows, we transform weeks of manual work into secure, actionable insights in minutes.
Empowering MedTech, From Pre-Market to Post-Market.
By automating data extraction, reporting, and regulatory workflows, we transform weeks of manual work into secure, actionable insights in minutes.
Pre-Market Solutions
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.
Pre-Market Solutions
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.
Pre-Market Solutions
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.
Post-Market Solutions
RegHero’s Post-Market Copilot™ empowers MedTech teams to monitor device safety, filter adverse events from unstructured data, and generate ready-to-submit MDR reports — all with AI-driven precision.
AI-Powered Adverse Event Detection
Automatically extract and identify adverse events from emails, call center logs, chat transcripts, and complaint reports.
Smart Case Triage & Prioritization
Automated routing of cases to quality, clinical, or regulatory teams.
Automated Regulatory Reporting
Generate ready-to-submit MDR (Medical Device Reports) for FDA
Post-Market Solutions
RegHero’s Post-Market Copilot™ empowers MedTech teams to monitor device safety, filter adverse events from unstructured data, and generate ready-to-submit MDR reports — all with AI-driven precision.
AI-Powered Adverse Event Detection
Automatically extract and identify adverse events from emails, call center logs, chat transcripts, and complaint reports.
Smart Case Triage & Prioritization
Automated routing of cases to quality, clinical, or regulatory teams.
Automated Regulatory Reporting
Generate ready-to-submit MDR (Medical Device Reports) for FDA
Post-Market Solutions
AI-Powered Adverse Event Detection
Automatically extract and identify adverse events from emails, call center logs, chat transcripts, and complaint reports.
Smart Case Triage & Prioritization
Automated routing of cases to quality, clinical, or regulatory teams.
Automated Regulatory Reporting
Generate ready-to-submit MDR (Medical Device Reports) for FDA
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
End-to-End Regulatory Automation
From pre-market clearance to post-market safety, 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 adverse event review
170k+
FDA-cleared devices indexed
3×
faster MDR reporting
Why RegHero
End-to-End Regulatory Automation
From pre-market clearance to post-market safety, 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 adverse event review
170k+
FDA-cleared devices indexed
3×
faster MDR reporting
Why RegHero
End-to-End Regulatory Automation
75%
Reduction in predicate search time
80%
reduction in manual adverse event review
170k+
FDA-cleared devices indexed
3×
faster MDR reporting
PRICING
Try RegHero Today
Pre-Market Essentials
For individual consultants & early startups
$99
/month
Full Access to AI-powered searches
Device Comparison
CSV Exports
Pre-Market Pro
For teams preparing multiple submissions
$299
/month
Everything in Essential, plus unlimited searches
Roadmap Planner
Document Drafting
Post-Market Enterprise plan
For post-market MedTech orgs
Custom
/month
Post-Market Copilot
Data integrations
Private workspace
PRICING
Try RegHero Today
Pre-Market Essentials
For individual consultants & early startups
$99
/month
Full Access to AI-powered searches
Device Comparison
CSV Exports
Pre-Market Pro
For teams preparing multiple submissions
$299
/month
Everything in Essential, plus unlimited searches
Roadmap Planner
Document Drafting
Post-Market Enterprise plan
For post-market MedTech orgs
Custom
/month
Post-Market Copilot
Data integrations
Private workspace
PRICING
Try RegHero Today
Pre-Market Essentials
For individual consultants & early startups
$99
/month
Full Access to AI-powered searches
Device Comparison
CSV Exports
Pre-Market Pro
For teams preparing multiple submissions
$299
/month
Everything in Essential, plus unlimited searches
Roadmap Planner
Document Drafting
Post-Market Enterprise plan
For post-market MedTech orgs
Custom
/month
Post-Market Copilot
Data integrations
Private workspace
© 2025, RegHero Inc.
© 2025, RegHero Inc.
© 2025, RegHero Inc.