The Audit Simulator for MedTech
We're building AI that thinks like a regulatory auditor—so you can catch compliance gaps before they become costly delays.
Who We Are
We are a team of regulatory experts and experienced executives, backed by world-class builders and researchers. Together, we're transforming how MedTech companies navigate the path to certification.
Our Mission
Medical device certification shouldn't take years of back-and-forth with Notified Bodies. Every revision cycle delays life-saving devices from reaching patients.
RegCheck exists to accelerate this process. Our AI screens documentation against thousands of regulatory requirements—exhaustively, consistently, and transparently—so manufacturers can fix gaps early and auditors can focus on what matters most.
We believe AI should augment human expertise, not replace it. Final certification decisions always remain with qualified professionals.
Regulatory Frameworks We Support
Security & Privacy First
Your regulatory documentation is sensitive. We offer both secure cloud and on-premise deployment options with strict data privacy standards.
Ready to Learn More?
Let's discuss how RegCheck can accelerate your certification timeline.
Contact Us