Senior expertise at reduced rates - design, R&D, regulatory, quality, and beyond. Built around your runway, not our billing model.
The Startup Program is for companies that need senior regulatory expertise but cannot yet support a full-time regulatory hire.
A focused working session to map your regulatory pathway, identify the highest-risk gaps, and prioritize your next 90 days. Flat rate, no commitment beyond the session.
Pathway determination, predicate analysis, classification rationale, estimated timeline and budget, and a prioritized action plan. Designed to be investor-ready.
Q-Sub meeting preparation including briefing document, FDA questions, and meeting coaching. Get FDA feedback before you spend money on the wrong tests.
A set number of hours per month at a reduced rate, giving you senior expertise without a full-time hire.
Full submission support at a fixed fee with milestone-based payments tied to your fundraising and development stage.
Right-sized ISO 13485 / QMSR implementation scaled to your headcount and product complexity.
Monthly or quarterly strategic check-ins without project-level commitment. Flexible guidance as your needs evolve.
Startup Program clients get early access to RAi to automate document drafting, QMS management, and 510(k) preparation between consulting sessions.
Try RAiQualifying companies receive reduced rates with several structures available:
Schedule a free 20-minute call to find out if you qualify and map your next 90 days.
Schedule a Free Consult