Serrah Namini

Serrah’s extensive experience includes ten years with the FDA as Consumer Safety Officer and Pacific Region Team Leader for Radiological Health team as well as four years working with Notified Bodies including Intertek. She has led global regulatory and quality departments and consulted for FDA regulated companies including startup, medium and large multi-site companies such as: USMC (orthopedics and prosthetics), Rhythm Technologies (electrophysiology PMA devices), Applied Medical (surgical devices), Nihon Kohden (patient monitors, EEG, EKG, EMG devices) and Karl Storz (surgical devices/monitors and endoscopes). She has prepared and submitted numerous successful 510(k)s for class II and III medical devices including implantable, electronics, software, lasers, electro-mechanical, surgical, and sterile. She has also setup Quality Assurance programs with validation processes to meet domestic and international standards/regulations including MDSAP requirements.