Executive-Level Regulatory Strategy for FDA, EU MDR & Global Markets

I help founders, executive teams, and investors make defensible regulatory decisions using risk-based strategy, regulatory precedent, and 17+ years of medical device experience.

Who I Work With

I work with medical device founders, executive leadership teams, and investors who need defensible regulatory direction to support critical business decisions.

  • Pre-submission and early commercialization companies determining FDA and EU MDR pathways

  • Growth-stage companies facing regulatory uncertainty, evidence expansion risk, or market delays

  • Investors and acquirers evaluating regulatory risk, feasibility, and downstream obligations

  • Leadership teams needing defensible regulatory positions aligned to business timelines

When Companies Typically Reach Out

Clients typically contact me when regulatory uncertainty begins to affect timelines, funding, or strategic decisions — and internal teams need clarity, not more documentation.

  • Uncertainty between 510(k), De Novo, PMA, or EU MDR conformity routes

  • Concerns about FDA or Notified Body evidence expectations changing mid-program

  • Conflicting internal opinions on regulatory strategy direction

  • Pressure from investors, boards, or acquirers to justify regulatory assumptions

  • Need for a senior regulatory perspective without hiring full-time leadership

My Approach

My work is grounded in regulatory precedent, risk-based decision-making, and practical experience navigating FDA, EU MDR, and global regulatory frameworks.

I help teams understand what regulators are likely to do, not just what guidance documents say — so decisions are defensible, proportionate, and aligned to business realities.

  • Regulatory strategy anchored in FDA and EU MDR precedent

  • Risk-based analysis tied to commercialization and funding milestones

  • Clear articulation of trade-offs, assumptions, and downstream implications

  • Executive-level communication suitable for boards and investors

What You Will Leave With

  • A clearly defined FDA and/or EU MDR regulatory pathway with rationale

  • Identification of potential evidence expansion triggers and risk areas

  • An understanding of regulatory expectations across jurisdictions

  • A prioritized regulatory roadmap aligned to business objectives

  • Clear next steps that leadership teams can act on with confidence

The goal is clarity — not more documents.

For companies seeking senior-level regulatory guidance.

© 2025 MD Regulatory Strategy. All rights reserved.

MD Regulatory Strategy provides strategic regulatory consulting services.

Services do not constitute legal advice, clinical advice, or regulatory authority determinations.

MD Regulatory Strategy may use analytical tools, structured evaluation frameworks, and decision-support technologies to assist with research, synthesis, and strategic analysis. All professional judgments, regulatory interpretations, and client-facing deliverables are independently reviewed and finalized by a qualified regulatory professional.