regulAIte
The Problem
Our Solution
Our Solution
Regulatory hurdles slow down innovation.
Medical device companies face:
- Fragmented global regulations
- Time-consuming documentation
- High cost of compliance
- Risk of delays or denials
You didn’t start your company to fight red tape. We did.
Our Solution
Our Solution
Our Solution
regulAIte is your AI-powered regulatory affairs team.
- Automate and guide 510(k), CE Marking, and MDR submissions
- Generate and validate documentation in real-time
- Stay updated with global regulatory shifts
- Ensure audit readiness and traceability
Think of us as your regulatory cofounder — available 24/7.
How It Works
Our Solution
How It Works
- Connect Your Product Info: Upload specs, intended use, and existing documentation
- Activate Your Copilot: Our AI suggests your optimal regulatory pathway and next steps
- Generate and Review: Create key documents (e.g., 510(k) summary, performance data, safety documents, etc...)
- Stay Compliant: Get alerts and guidance throughout the lifecycle
Who It's For
Our Solution
How It Works
- Early-stage medical device startups
- Regulatory consultants & RA teams
- Healthtech and SaMD innovators
- Companies entering US, EU, or India markets
Why Choose regulAIte
Expertise
- Built by regulatory professionals
- Proprietary AI trained on real regulatory data
- Global-ready: FDA, MDR, IVDR, CDSCO and more
- Continuous learning & adaptation
- Explainable, auditable AI
Regulation isn’t just a checkbox. It’s your competitive edge.