Regulatory Clarity
when it matters
Decision-Level Strategy Delivered Directly
Medical Device Regulatory Consulting
Regulatory Strategy & Pathway Assessment
- Regulatory strategy development aligned with program timing, resource constraints, and business objectives
- Regulatory pathway assessment
- Q‑Submission (Q‑Sub, Pre-Sub) strategy for FDA feedback and risk reduction
- Interpretation and application of agency guidance and current regulatory thinking for specific device technologies
Premarket & Agency Engagement
- Submission planning and management, including FDA 510(k) and De Novo (also PMA when unavoidable)
- Administrative pathway determinations, e.g. 513(g) requests for classification
- Regulatory authority interactions, including meeting strategy, formal correspondence, and issue resolution
- Advocate for FDA’s “Least Burdensome Approach” requirements
- Technical documentation, technical file support, and device labeling development
Other Planning and Support
- Risk management strategy for device classification and clinical study (IDE)
- Human factors consideration
- Establishment registration (foreign and domestic) and product/device listing
- Support for regulatory inspections, audits, and related agency reviews
Meeting Your Stakeholder's Needs
Our work supports medical device companies through regulatory challenges by aligning global regulatory strategy with business objectives, investor priorities, patient impact, and regulatory expectations. Our results work to ensure regulatory decisions are informed, realistic, and appropriate for the full set of stakeholders involved.
