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Whether you need help with MAUDE searches, formative study planning, recruitment screeners, or full HF report generation. We'd love to hear about your regulatory challenges.
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Whether you're a 10-person startup or a $500M medtech division, Submitta scales to your regulatory documentation needs.
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Frequently Asked Questions
What can Submitta help with beyond final reports?
Submitta supports the full HF workflow: FDA MAUDE database searches, recruitment screener generation, formative study planning and protocols, and automated report drafts. More capabilities are launching regularly.
How long does it take to generate a report?
Submitta produces a structured, review-ready first draft in minutes. This compares to 2–3 months and $50K+ with traditional consultant approaches.
Are outputs reviewed by human experts?
Yes. Human regulatory experts review every output, AI speed, expert accuracy. Our models are trained on proprietary data from experienced human factors engineers.
Is my data secure?
Customer data is fully isolated. Submissions are never used to train or improve models across accounts. Enterprise-grade encryption at rest and in transit.