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The Problem
Re-entering data across dozens of forms.
Juggling PDFs, Excel, and conflicting emails.
Searching for product codes is error-prone.
Re-entering data across dozens of forms.
Juggling PDFs, Excel, and conflicting emails.
Searching for product codes is error-prone.
The Solution
Visualize data, requirements, and compliance metrics easily. Integrate with official FDA, EU MDR, and global databases.
Instantly apply regulatory rules, formatting, and required standards so every document is always submission-ready.
Export your strategy reports and eSTAR templates straight to submission formats.
Full control over strategy layouts and visuals without breaking regulatory rules.
Collaborate with your regulatory affairs team. Share drafts and manage permissions.
Your proprietary medical data stays private, protected by enterprise-grade security.
How It Works
Complete our adaptive 35-question wizard. Our system gathers clinical and technical data to build your device's unique profile.
Our AI engine cross-references your data with FDA and EU MDR databases to identify the precise regulatory path and product codes.
Download your complete strategy report, predicate mappings, and pre-filled eSTAR templates—ready for submission.
FAQs
Join hundreds of medical device manufacturers who trust Qualicom AI to generate their FDA eSTAR and EU MDR submissions 10x faster.
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