Galina Nitsa/QM

Galina Nitsa has over 25 years’ experience in the medical device industry with deep expertise in risk management, design controls, and regulatory compliance for complex medical systems. She provides technical leadership in product risk management, guiding cross-functional teams to develop compliant and safe medical devices across the full product life cycle. Her experience includes leading system risk management activities, preparing regulatory submissions, and supporting design and production processes in accordance with FDA QSR and ISO 13485 requirements. Her technical background includes monitors and defibrillators, infusion pumps, dialysis devices, and diagnostic imaging systems. She holds a Master of Science in Mechanical and Manufacturing Engineering from Odessa State Polytechnic University.