Regulatory Clarity When It Matters
Decision-Level Strategy Delivered Directly
Medical Device Regulatory Consulting | FDA Strategy
Medical Devices | any Type
In-Vitro Diagnostics (IVD)
Wellness Devices
Combination Devices
Regulatory Strategy & Pathway Assessment to Provide Regulatory Clarity
- Strategy development that considers both near and long-term plans
- Evaluation of regulatory pathways in light of business objectives and constraints
- Strategic assessment for the use of Q‑Submissions (Q‑Sub, Pre-Sub)
- Identification of device risks and rewards to inform decision-making
- Application of agency guidance and current thinking that is specific to the device’s technology and intended use
Planning & Agency Engagement to Bring Your Product to Market
- Premarket submission planning and management, including FDA 510(k) premarket notification and De Novo pathways (and PMA where other alternatives are not viable)
- As part of early pathway planning, evaluation of administrative and classification routes, including 513(g) requests
- Regulatory authority engagement, including meeting strategy, formal correspondence, and issue resolution
- Strategic application of the FDA’s Least Burdensome Approach, to support reasoned, proportionate agency requests
- Review and refinement of technical documentation, internal test report elements, and device labeling to support submission readiness
Additional Planning and Support for Device Specific Needs
- Risk management development for device classification and clinical study (IDE risk level determination)
- 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 advisory supports medical device companies through regulatory challenges by aligning global regulatory strategy with business objectives, investor priorities, patient impact, and regulatory expectations. Accordingly, this approach works to ensure regulatory decisions are informed, realistic, and appropriate for the full set of stakeholders involved.
