FDA Regulatory Strategy & QMS/DHF Setup
Ensure Compliance. Accelerate Approvals. Protect Innovation.
​
Navigating regulatory pathways is one of the most critical and complex challenges in bringing medical technologies to market. From FDA 510(k) and De Novo submissions to EU MDR compliance, every step requires meticulous planning, technical expertise, and strategic foresight. Missteps can delay approval, limit market access, or even compromise patient safety.
​
As a Medical Device Expert, I guide startups, growing ventures, and established MedTech companies in building the frameworks that ensure regulatory compliance, streamline approvals, and protect your intellectual property and innovation. My approach is practical, strategic, and designed to align regulatory rigor with business objectives.
Build a Robust Regulatory Strategy
A comprehensive regulatory strategy is the foundation of a successful medical device launch. I help organizations:
​
• Assess the appropriate regulatory pathway, 510(k), De Novo, PMA, or CE marking
• Identify applicable standards and guidance for safety, performance, and labeling
• Integrate regulatory considerations early in product design to reduce costly delays
• Align submissions with market entry goals in the U.S. and EU
​
By anticipating challenges and embedding regulatory strategy into development, you achieve approvals faster and with greater confidence.
Design History Files & Quality Systems That Deliver
Strong quality systems and complete design history files (DHF) are essential for compliance and long-term market success. I provide hands-on guidance in:
​
• Developing FDA-compliant QMS aligned with ISO 13485 and FDA requirements
• Creating and maintaining design controls and DHFs that document product development
• Ensuring traceability from design inputs to verification, validation, and risk management
• Preparing your organization for audits, inspections, and regulatory reviews
​
These systems not only satisfy regulators; they instill trust among investors, partners, and clinical stakeholders.
Navigate Risk & Reimbursement with Confidence
Product, market, fit success is closely tied to understanding payor and reimbursement options. I work with leadership teams to:
​
• Identify potential compliance risks and mitigation strategies
• Align regulatory pathways with reimbursement opportunities and payer expectations
• Support submissions with clear clinical and technical documentation that demonstrates value
​
This integrated approach helps products reach patients safely while maximizing business impact.
Why Work with Me
Over two decades in MedTech, as a 3× CEO, inventor, and strategist, I’ve launched over 25 life-saving medical products globally and secured 20+ patents. My experience spans regulatory strategy, product commercialization, investor engagement, and international market entry. I’ve helped companies of all sizes translate innovation into market-ready devices, ensuring compliance and accelerating adoption.
Protect Your Innovation. Reach the Market Faster.
Regulatory strategy and quality systems are not just checkboxes: they’re strategic levers for business growth and patient impact. Let’s design a pathway that safeguards your technology, satisfies regulators, and positions your device for commercial success.