This engagement provides founders and their investors with a clear, defensible regulatory starting point for a medical device or regulated digital health product entering the U.S. market. The Regulatory Overview Memorandum is designed as a foundational decision-making document, often the first formal regulatory artifact used to align founders, boards, investors, and development teams before significant capital is deployed. I work closely with the founding team to analyze the intended use, technical claims, risk profile, and commercial roadmap, then translate that into a structured FDA pathway assessment. The output is practical, not academic, and intended to support product planning, fundraising, and early design decisions. This engagement is especially valuable for early-stage companies that need regulatory clarity before MVP finalization, investor discussions, or pilot programs. Length: 40-60 pages.

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Advisory Scope Summary

- Device classification assessment (FDA class & product code) - Likely regulatory pathway (510(k), De Novo, PMA, enforcement discretion, etc.) - Predicate device landscape (where applicable) - High-level clinical, quality, and evidence expectations - Key regulatory risks and assumptions - Recommended next regulatory steps, scenario analysis, and decision gates