MedevAI: Agentic Medical Device Regulatory Pathway Planner

Streamline FDA regulatory pathway planning with AI-powered predicate search and compliance automation—reducing 510(k) preparation time from weeks to hours.

id="app-details-left"> Inspiration Bringing a medical device to market is fraught with regulatory hurdles, where even a single misstep contributes to a 15% submission failure rate. We developed MedevAI after witnessing startups lose precious time and resources on the manual, error-prone search for predicate devices, reference guidance, and the setup of practical device tests and clinical trials. These bottlenecks aren’t caused by a lack of data, but by the lack of accessible tools to integrate it; the FDA’s open data is a treasure trove that remains locked for most. MedevAI is the key. It was…

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