AI-Powered Regulatory Intelligence

Welcome to SittuAI Your Regulatory Submission Copilot

Harness the power of advanced AI to streamline your 510(k) submissions. Our intelligent platform automates 80% of your regulatory documentation while ensuring FDA compliance.

340+
Hours Saved Per Submission
24
Co Pilot Generates Documents
10K+
FDA Public Records Analyzed
98%
First-Pass Acceptance Rate

Intelligent Capabilities

Powered by proprietary AI technology designed specifically for FDA regulatory workflows

AI Document Generation

Automatically generates 24+ compliant regulatory documents tailored to your device profile and FDA requirements.

24+ Documents
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Knowledge Graph

Connected intelligence that understands device relationships, regulations, and FDA guidance documents.

Sophisticated Connections
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Compliance Validation

Real-time validation against 21 CFR requirements and current FDA guidance documents.

Auto-Verified
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Simple 4-Step Process

From device profile to FDA-ready submission package

1

Define Your Device

7-step guided wizard

2

AI Analysis

Find predicates & gaps

3

Generate Documents

24+ docs auto-drafted

4

Export Package

eSTAR-ready format

SOC 2 Compliant
HIPAA Ready
Azure Enterprise
Data Encrypted

Ready to Transform Your Regulatory Submissions?

Join leading medical device companies who have reduced their 510(k) preparation time by 60%.

or email us directly at info@sittuai.com