DiGangi Consulting LLC

Regulatory Clarity When It Matters

Decision-Level Strategy Delivered Directly

Medical Device Regulatory Consulting

Senior Medical Device Regulatory Strategy and FDA Advisory

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 regulatory tradeoffs 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
  • Principled application of the FDA’s Least Burdensome Approach, to support reasoned, proportionate agency requests
  • Targeted review and refinement of technical documentation, internal test report elements, and device labeling to support submission readiness

Depending on device type and development state, additional support may include:

  • 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
  • Other regulatory advisory discussions relevant to your device and company goals 
Contact us for An Initial Regulatory Consultation
US FDA Medical Device Regulatory Strategy

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.
Learn More About Our Approach
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