Targeted intervention tiers for early-stage founders and lean teams developing Class II and III implantable devices.
Stop guessing. I provide classification analysis, regulatory/product code determination, and a gap analysis of your existing data. Includes a high-level testing and clinical plan.
Build a compliant foundation. Detailed content mapping, document templates, and an exhaustive RTA checklist against your content before you draft.
Maximize your clearance chance. Hands-on co-drafting, AI letter response structuring, meeting prep, and direct FDA interaction management.
Retain "Insider" Oversight. Monthly ad hoc support for design reviews, labeling/claims advice, and product pipeline planning.