ConsultingContact Me
Regulatory strategy for innovative healthcare companies.
I work with a small number of healthcare and diagnostics companies each year, advising on the regulatory questions that shape whether a product ever reaches a patient.
FDA Strategy
- Regulatory pathway assessment
- De Novo strategy
- 510(k) planning
- FDA interactions
AI/ML Medical Devices
- AI governance
- SaMD strategy
- Documentation planning
Quality & Compliance
- Design controls
- Risk management
- Cybersecurity documentation
Startup Advisory
- Regulatory team building
- Scaling quality systems
- Investor and leadership support
Have a regulatory question worth getting right?
Tell me about your product and timeline — I’ll let you know if I’m the right fit.