Medical Device Regulatory Clarity
We define viable regulatory pathways that make regulatory risk and tradeoffs explicit for decision-makers.
Strategy Across Technologies
Early regulatory choices materially influence development timelines, investment risk, time to market, and long-term flexibility. From the outset we develop a regulatory strategy that anticipates downstream implications across all device types, including:
- In-Vitro Diagnostics (IVD)
- Software as a Medical Device (SaMD)
- Combination Products
- Wellness Devices
Regulatory Strategy
Regulatory strategy requires balancing near‑term development decisions with long‑term business and regulatory objectives. Accordingly, our work focuses on defining viable regulatory pathways early, clarifying associated tradeoffs, and structuring decisions to preserve flexibility where possible.
In practice, regulatory strategy includes:
Foundational strategy & pathway definition
- Integrated regulatory strategy development that considers both near‑ and long‑term objectives
- Evaluation of potential regulatory pathways in light of business goals, constraints, and timing
- Assessment of prior agency interactions and the most likely submission route
Classification & positioning
- Development of a working understanding of device technology and intended use to inform preliminary regulatory classification
- Identification of prior art, applicable predicates, and reference devices that may support safety and effectiveness
- Strategic assessment of whether and when to engage the FDA through pre‑submission mechanisms (Q‑Sub, Pre‑Sub)
- Evaluation of administrative and classification routes, including 513(g) requests where appropriate
Regulatory risk & downstream considerations
- Identification and framing of device‑specific regulatory risks and tradeoffs
- Application of relevant agency guidance and current FDA thinking specific to the device and intended use
- Early identification of data expectations and potential evidentiary gaps that may affect feasibility, timing, or cost
Agency Engagement and Submissions
Once regulatory strategy is established, focus shifts to disciplined execution and effective agency interaction. Regulatory assumptions, risk framing, and positioning are reassessed as new information emerges to maintain alignment throughout the process.
- Determining and planning of initial regulatory steps and submission type (e.g., Q-Submission, 510(k), De Novo, Breakthrough Device Designation (BDD), administrative routes), as appropriate
- Regulatory authority engagement, including meeting strategy, agenda development, formal correspondence, and issue resolution
- Use of FDA’s Least Burdensome Provisions as an active framework for evaluating and responding to agency information requests
- Targeted review and refinement of technical documentation, test reports, and device labeling to support submission readiness
- Preparation for and interpretation of agency feedback, including adjustment of development plans or submission approach where warranted
Additional Regulatory Advisory
- Design control considerations, pre- and post-submission
- Risk management development to support device classification and clinical study (e.g., IDE risk determination)
- Human factors and usability considerations aligned with FDA guidance and ISO/IEC 62366, as applicable
- Advisory support for software as a medical device (SaMD) or software integral to a device, including artificial intelligence (AI) considerations
- Establishment registration (foreign and domestic) and product or device listing
- Support for regulatory inspections, audits, and related agency reviews
- Assessment of quality management system readiness (e.g., FDA QMSR and ISO 13485)
- Regulatory considerations for supplier qualification and manufacturing, including quality management system (QMS) readiness
- Targeted advisory on regulatory risk exposure during investment, partnering, or acquisition activities
- Other regulatory advisory discussions relevant to the device, organization, or company objectives
Investor Due Diligence
Investment and acquisition decisions involving medical devices often hinge on regulatory and quality assumptions that are difficult to fully validate using deal materials alone. Our diligence work focuses on independently assessing regulatory soundness, quality system maturity, and manufacturing readiness to surface risk early—before commitments are made.
We work directly on behalf of investors, acquirers, and corporate development teams to evaluate whether a company’s regulatory positioning, development plans, and operational foundations are credible, defensible, and aligned with current regulatory expectations. This includes identifying misalignment between stated strategy and regulatory reality, areas of unrecognized risk, and decision points that could materially affect valuation, timing, or long‑term flexibility.
Diligence engagements are judgment‑driven and senior‑led, drawing on deep regulatory, quality, and manufacturing experience to provide investors with clear, independent insight to support informed investment, partnership, or acquisition decisions.
Typical diligence focus areas include:
- Regulatory pathway credibility and underlying assumptions
- Classification and submission strategy risk
- Quality system maturity and inspection readiness
- Manufacturing and supplier regulatory readiness
- Device risk, human factors, clinical, and post‑market considerations with downstream impact
- Alignment between regulatory claims, documentation, and operational reality
Meeting Your Stakeholder's Needs
Ultimately, regulatory strategy succeeds only when it aligns its results with the needs of its stakeholders.
Our advisory connects regulatory strategy with business objectives, investor priorities, patient impact, and regulatory expectations—applied through a least‑burdensome, risk‑appropriate lens.
The result is durable regulatory pathways that integrate into leadership planning, investor communications, and regulatory authority interactions.
