Great companies are built by exceptional founders. Great investments are made by experienced investors. Neither should have to become regulatory experts to make confident decisions.

What I Do

Regulatory Strategy for Medical Device Investors and Innovators

I help investors evaluate regulatory risk and help medical device companies build regulatory strategies that support successful development, commercialization, and marketing needs.

Who I Work With

Investors

• Regulatory diligence
• Investment risk assessment
• Portfolio advisory

Medical Device Companies

• Regulatory strategy
• Fractional Regulatory Leadership
• Clinical and Regulatory planning
• Submission documentation

Why Clients Choose Me

• 20+ years of regulatory leadership across US FDA and EU MDR
• Experience spanning SaMD, orthopedics, ophthalmology, trauma, wound management, CMF, oncology, patient-specific devices, and digital manufacturing
• A practical, business-focused approach - not just regulatory compliance
• Able to communicate effectively with executives, founders, engineers, clinicians, and investors

What Clients Ask Me

• Are our FDA pathway and timelines realistic?
• What regulatory risks should we understand before investing?
• How will EU MDR impact our timeline?
• Should we pursue 510(k), De Novo, or PMA?
• Will we need a Q-Sub?
• Will we need to collect Clinical evidence?