Jodi Scott

Widely regarded as a fixer in the medical device industry, Jodi helps companies respond to and recover from FDA inspections, Form 483 observations, warning letters, and enforcement actions. Her calm, strategic leadership ensures clients maintain compliance while protecting business continuity and reputation.

Jodi advises on FDA regulatory strategy, quality system regulations (QSR), medical device reporting (MDR), and recall management, aligning regulatory obligations with business goals. As a certified ISO 13485 auditor, she prepares companies for FDA, ISO, and MDSAP audits, and supports post-market compliance and state licensing requirements.

As co-leader of the firm’s AI & Digital Health Working Group, Jodi counsels on AI-enabled medical technologies, software as a medical device (SaMD), machine learning diagnostics, and wearable health devices. She also advises on general wellness products outside FDA oversight, helping clients accelerate market entry while minimizing regulatory risk.

Her practice spans the full product lifecycle, including regulatory due diligence for mergers and acquisitions (M&A), commercialization planning, and risk mitigation strategies. Jodi helps clients stay ahead of evolving FDA policies, leverage emerging technologies, and maintain compliance while gaining a competitive edge in the healthcare marketplace.