Farhan Shahab - Vice President Quality

Farhan Shahab has served as our Vice President of Quality since November 2025. Farhan is an innovative Regulatory and Quality executive who has deep experience architecting enterprise-level quality transformations and pioneering regulatory strategies that accelerate innovation, enable commercialization, and ensure patient safety. Throughout his career, Farhan has built and scaled FDA and ISO 13485-compliant Quality Management Systems across global organizations, secured U.S. and international approvals (FDA, EU, Health Canada, PMDA), and led complex audits. He has guided regulatory integration for acquisitions exceeding $5B and advanced novel pathways for catheters and Software-as-a-Medical-Device (SaMD) technologies in collaboration with the FDA and Notified Bodies. Farhan’s leadership reflects a deep commitment to aligning compliance with corporate growth and empowering organizations to operate with integrity, innovate responsibly, and deliver safe, effective, and high-quality products worldwide. Before joining our company, Farhan served as Vice President of Quality and Regulatory at Welldoc, Inc., a privately held manufacturer of FDA-cleared digital health platform that helps people manage cardiometabolic conditions like diabetes, hypertension, weight and heart health through AI-personalized coaching and real-time insights. Prior to that, Farhan served as Senior Director of Quality and Regulatory at Intuity Medical, Inc., a diabetes company specialized in the manufacture of blood glucose monitors, cartridges, control solution and SaMD application. He earned a Bachelor of Science in Chemical Engineering and a minor in Resource Economics and Chemistry from the University of Massachusetts, Amherst and earned his MBA from the University of Phoenix, Oxnard. Farhan holds many certifications including CQE (Certified Quality Engineer), CSSBB (Certified Six Sigma Black Belt), Certified Quality Auditor and RAC (Regulatory Affairs Certification).

Have questions?
CALL US NOW
: (800) 624-1179
Have questions?
EMAIL US NOW
: info@biocardia.com