Hany Mahmoud

Hany Mahmoud is a seasoned Quality and Regulatory expert in the medical device industry, with experience gained at Philips and Fresenius. Hany is an ISO 13485 Lead Auditor and a Technical File Reviewer, supporting teams in meeting ISO 13485, EU MDR, and FDA requirements. His work covers quality systems, regulatory compliance, design controls, risk management, and post‑market activities. He holds an engineering bachelor’s degree and the recognized Certified Manager of Organizational Excellence (CMOE) credential from ASQ. Hany is also an experienced trainer who delivers clear, practical, and easy‑to‑understand sessions that help teams apply quality and regulatory rules with confidence. His focus is on building a strong quality culture and helping organizations deliver safe and effective medical devices.