Regulatory Strategy Advisory
FDA and EU MDR pathway guidance grounded in regulatory precedent and risk-based decision-making to support critical business timelines.
Fractional Director-Level Oversight
Senior regulatory leadership without the commitment of a full-time hire, providing strategic direction when you need it most.
Submission Readiness
Quality review and peer assessment of regulatory submissions to identify gaps and strengthen defensibility before submission.
Cross-Jurisdictional Strategy
Alignment of FDA and EU MDR strategies to avoid unintended evidence expansion and regulatory conflicts.
Regulatory Diligence
Transaction and investment diligence to evaluate regulatory risk, feasibility, and downstream obligations.
Change Control Risk Assessment
Evaluation of regulatory implications for product changes, ensuring appropriate pathways and evidence requirements.
Medical Device Founders
Pre-submission and early commercialization companies determining FDA and EU MDR pathways and evidence strategies.
Executive Leadership
Growth-stage companies facing regulatory uncertainty, evidence expansion risk, or strategic decision points.
Investors & Acquires
Investment and acquisition teams evaluating regulatory risk, feasibility, and commercial timeline assumptions.
Clients typically contact us when regulatory uncertainty begins to affect timelines, funding, or strategic decisions, and internal teams need clarity, not more documentation.
Common scenarios include:
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 senior regulatory perspective without hiring full-time leadership.
Our work is grounded in regulatory precedent, risk-based decision-making, and practical experience navigating FDA, EU MDR, and global regulatory frameworks.
We 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.
A clearly defined FDA and/or EU MDR regulatory pathway with rationale.
Identification of potential evidence expansion triggers and risk areas.
Understanding of regulatory expectations across jurisdictions.
Prioritized regulatory roadmap aligned to business objectives.
Clear next steps that leadership teams can act on with confidence.
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Strategic regulatory consulting for medical device companies navigating FDA, EU MDR, and international markets.
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MD Regulatory Consulting Inc.