Farhan Shahab

FARHAN SHAHAB, M.B.A., vice president of quality at BioCardia, Inc., is a seasoned management professional with over 25 years of leadership experience in quality systems, regulatory affairs, and process improvement within the medical device and digital health industries. He has held executive positions at firms including Welldoc, Intuity Medical, AngioScore, and Medtronic, specializing in FDA, Notified Body, and PMDA regulatory compliance.

A recognized expert in design controls (21 CFR 820.30), Shahab has spearheaded the development of robust frameworks for software as a medical device (SaMD) and AI-driven healthcare solutions. His technical expertise includes navigating the complexities of design verification and validation (V&V), implementing risk management (ISO 14971) protocols, and establishing traceability matrices that bridge innovative product development with rigorous safety standards. He has extensive experience leading predetermined change control plan (PCCP) strategies for 510(k) submissions, ensuring that iterative AI model improvements remain compliant throughout the product lifecycle.

Shahab has a Bachelor of Science in Chemical Engineering from the University of Massachusetts, Amherst, and an M.B.A. from the University of Phoenix. Additionally, he holds certifications including RAC-US, CSSBB, and CQE, and serves as an instructor at UCSC Silicon Valley Extension, where he translates complex regulatory requirements into actionable engineering practices for the next generation of industry professionals.