Shaherah Yancy

Help with FDA Submission, clinical study work, and background documentation/analysis

• 20+ years of clinical, regulatory, and commercialization leadership in MedTech and life sciences.

• Former roles leading clinical affairs at global device companies with extensive regulatory pathway and FDA strategy expertise.

• Founder of a regulatory consultancy helping early-stage companies navigate quality systems, clinical strategy, and market entry.

Clinical & Regulatory Strategy Advisor (Advisor)