Pick the problem you have. Here's what I do about it.

“Our grant application is due and nobody's checked the development plan.”

Grant and Proposal Technical Review

A written review of the technical plan against design controls and the FDA pathway, with specific fixes.

What you get

• A written review of the technical plan against design controls
• A check of the proposed FDA pathway and the evidence it will need
• Gaps flagged where test thresholds stand in for design requirements
• Specific fixes you can make before the deadline

“Investors keep asking how we get cleared and what it'll cost.”

Regulatory Pathway Assessment

Recommended pathway (510(k), De Novo, or PMA), predicate candidates, evidence plan, and a rough timeline and cost.

What you get

• A recommended pathway: 510(k), De Novo, or PMA, with the reasoning
• Predicate device candidates and how your device compares
• An evidence plan covering the bench, animal, and clinical testing you are likely to need
• A rough timeline and cost to clearance

“We have test reports, but no user needs or design inputs behind them.”

Design Controls Gap Review

A gap report against FDA's QMSR and ISO 14971, a ranked fix list, and a readout with your team.

What you get

• A gap report against FDA's QMSR and ISO 14971
• A fix list ranked by regulatory risk
• What your design and development file needs before submission
• A readout with your team to walk through the findings

“We're about to invest and need an independent technical read.”

Technical Due Diligence

Regulatory pathway, design controls maturity, technical risk, and a written report for investors.

What you get

• A review of the regulatory pathway against the company's plan
• An assessment of design controls maturity
• Technical risk across design, manufacturing, and IP position
• A written report for investors

“We got a 483 (or a deficiency letter) and need help now.”

FDA Findings Remediation

Response strategy and hands-on design controls remediation alongside your quality team.

What you get

• A response strategy and plan for each finding
• A review of the design controls behind each finding
• Hands-on remediation alongside your quality team
• Coordination across engineering, quality, and regulatory

“We need someone senior to own R&D, but not full time.”

Fractional CTO

Ongoing technical leadership on a monthly retainer.

What you get

• Ownership of the technical roadmap and regulatory pathway
• Design controls and risk management built into how the team works
• Hiring, mentoring, and leading the engineering team
• A team that keeps moving when I am not in the room