Cruxi

Cruxi is a web-based AI platform that helps medical device teams and regulatory consultants plan, draft, validate, and package FDA 510(k) submissions faster.

Key capabilities include:

510(k) drafting support aligned to common submission sections and best practices

Device pathway and requirements guidance (with structured knowledge from FDA sources)

Predicate discovery and side-by-side comparison tools

Change impact and modification analysis for existing devices

eSTAR package checks and submission validation workflows

Consultant directory to match startups with experienced 510(k) reviewers

Cruxi is built for regulatory professionals who want to reduce manual research and formatting work while keeping experts in control of the final submission

Cruxi also maintains the biggest directory of FDA 510K Consultants https://cruxi.ai/pages/regulatory/fda-510k-consultant.html