Gabriele Bellandi, MSc

Gaby has been in the MedTech industry for 15 years, with 10 years focused on In-vitro diagnostics (IVDs) and 1.5 years focused on medical devices specifically in the field of Extractables & Leachables (E&L) testing.

Gaby joined NAMSA in 2023. Before joining NAMSA, she worked at Siemens Healthineers for almost a decade in various roles, most recently as a Project Manager for development projects (FDA, CE Mark). During her time as a supervisor at Siemens she gained extensive experience in risk management according to ISO 14971. She has focused on the planning and coordinating of technical development projects (reagents, software, instruments) in the medical device industry as well as planning and monitoring of corresponding capacities and deadlines.

Gaby holds a Master’s degree in Bioinformatics/Biosystems Technology.

CORE COMPETENCIES

• Heading the test facility for Obernburg and maintaining compliance to ISO 17025
• Providing leadership, planning, coordination, and oversight of the European Analytical Services Team
• Coaching and development of talent within the European Analytical Services Team
• Managing research activities, including method development and qualification/validation
• Ensuring studies are conducted according to applicable regulations and procedures with a high ethical/quality of standards
• Overseeing study execution to ensure studies are completed on time, within budget and in compliance with SOPs, guidelines, and applicable regulations
• Project management (Certified Senior Project Manager [IAPM])