Cruxi Information

Cruxi is an AI-powered regulatory platform that helps medical device teams plan and prepare FDA 510(k) submissions faster, with more confidence and less manual work. Built for startups, small and mid-sized manufacturers, and regulatory consultants, Cruxi guides you from early device classification through evidence planning and eSTAR-ready drafting. The platform combines structured regulatory knowledge (product codes, regulations, standards, and guidance) with AI workflows to help you: – Identify product codes and likely regulatory pathways – Map applicable guidance, standards, and special controls – Build a clear evidence plan and organize documentation – Draft key eSTAR-aligned sections with citations to source texts Teams can choose between full 510(k) workflow support or focused micro-services (e.g., classification, evidence planning, or section drafting) depending on their needs and budget. When expert human review is required, Cruxi’s integrated consultant directory lets users connect with experienced regulatory professionals who can review AI-generated work and finalize submissions. Our goal is simple: reduce the time, risk, and cost of getting safe medical devices to patients by making high-quality regulatory work more accessible through AI and trusted experts.