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Cruxi is a vertical AI platform built specifically for medical device regulatory teams. It ingests FDA regulations, guidance, product codes, standards, MAUDE events, recalls, and prior 510(k) data to power agentic workflows for 510(k), De Novo, and eSTAR. Users can run rapid device classification, compare predicates, plan evidence, and generate fully cited, eSTAR-aligned content for each subsection of the submission. Cruxi offers both full-submission workflows and focused micro-services (e.g., classification, predicate analysis, specific section drafting), making it ideal for early-stage startups, in-house regulatory teams, and consultants who want to deliver high-quality submissions with less manual work and fewer surprises from FDA.
80 pinewoord road, 10530, Hartsdale, United States
3.3
2 reviews
Hasn’t replied to negative reviews
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This was not a great experience. From the beginning, communication felt unorganized and confusing. I had to follow up multiple times just to get basic information. In the end, the result didn’t match what was promised, and no one really took responsibility. As a paying customer, I just wanted things to be handled professionally. Unfortunately, I left feeling frustrated and unheard.
This is a revolution in the FDA regulatory domain!
I can't comprehend how this works!! I just ran a predicate search for a tricky device -- Incredible 15 mins and boom! It literally made a research for all possible predicates with detailed analysis -- I call it revolutionary because this is gonna change the market landscape no more 10s of thousands and no more weeks to wait! Highly recommended
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