From Expert Guidance to Accelerated FDA Clearance: Your Complete Partner for AI-enabled Medical Device Success
You innovate at the forefront of medical AI — we ensure regulatory compliance and FDA success. We provide a one-stop solution for bringing next-generation AI/ML Software as a Medical Device (SaMD) to market faster and with confidence.
Trusted by Medtech Startups, Led by Former FDA and Industry Experts in Medical AI
Our Services
Comprehensive solutions for FDA regulatory compliance
Rapid Expert Guidance
On-Demand Expert Consulting
START: You have FDA questions or uncertainties about your product.
PROCESS: Get 1:1 expert guidance from FDA veterans within 24h.
RESULT: Clear answers to meet FDA expectations, avoiding wasted time and cost.
SERVICES:
- Expert opinion on AI model evaluation
- Indications for use and claims guidance
- Cybersecurity and software documentation
- FDA AINN deficiency response
Regulatory Partner
Strategy to Guaranteed Clearance
START: You need a clear FDA submission pathway.
PROCESS: Full support at every stage, from product development and evaluation to FDA submission.
RESULT: Streamlined process, reduced rework, and faster FDA clearance.
SERVICES:
- Full-service 510(k) or De Novo submission
- Regulatory strategy, claims, study design, and Q-sub
- Performance testing protocols and guidance
- FDA submission drafting, review, and defense
Cybersecurity Compliance
Zero Cybersecurity Deficiency
START: You need your product to meet FDA cybersecurity requirements.
PROCESS: We identify cybersecurity risks, apply risk controls, validate, and document.
RESULT: Built-in cybersecurity compliance with complete documentation for FDA clearance.
SERVICES:
- Full-service FDA cybersecurity support
- Threat modeling and SBOM generation
- Penetration testing and vulnerability analysis
- Secure SDLC/SPDF consulting
Why RegMedAI?
Discover what sets us apart in FDA compliance for AI-enabled medical devices.
FDA Experts
Led by former FDA and industry veterans, we provide unmatched regulatory expertise for AI/ML SaMD.
Guaranteed Success
Clearance guarantee for client submissions in early engagement model, with rapid turnaround and clear guidance at every step.
End-to-End Support
From idea to commercialization, we cover every aspect of FDA compliance for medical AI software.
We specialize in medical AI regulation and product development.
Our expertise covers the full spectrum of deep regulatory needs for AI/ML SaMD.
Let's Navigate Your FDA Journey Together
Ready to accelerate your FDA submission? Choose how you'd like to connect with our regulatory experts.
We typically respond within 24 hours
Get in Touch
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