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Regulify.AI
↗Addison, Texas, United States
Regulify.AI is an early-stage MedTech startup that provides an AI-augmented platform designed to streamline the medical device product lifecycle. The company focuses on automating complex regulatory documentation—such as DHF, DMR, and QMS—to help MedTech companies reduce go-to-market timelines and costs by over 50%.
The platform integrates engineering expertise with AI to support various medical device types, from simple instruments to complex implantables and Software as a Medical Device (SaMD). By offering tools like a Pre-Sub Accelerator and Compliance Checker, Regulify.AI aims to bridge the gap between medical innovation and regulatory certification.
CLASSIFICATION
Company Type:Digital Health
Therapeutic Areas:-
Industry:Digital Health
Sub-Industry:MedTech Regulatory Technology
SIZE & FINANCIALS
Employees:1-50
Revenue:$0M-$1M
Founded:2025
Ownership:private
Status:operating
FUNDING
Stage:Pre-Seed
Total Raised:$0.1M
0
COMPETITION
Position:Emerging
LEADERSHIP
Key Executives:
Gurvinder Walia - Co-Founder
Kundan Krishna - Co-Founder
LINKS
Website:regulify.ai
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