Welcome Helene Wu, Ph.D. to the GessNet team

GessNet combines expert consulting with purpose-built digital solutions to help life-science companies connect and streamline product development, quality, risk management, and regulatory execution around product safety and effectiveness. Helene brings more than 20 years of medical device industry experience, including roles at BD, Abbott, and GE Healthcare, with deep expertise in drug-delivery systems, drug-device combination products, Class II/III medical devices, IVDs, and software-enabled connected devices. Her experience spans systems engineering, design controls, ISO 14971 risk management, software and cybersecurity, human factors, V&V, supplier and manufacturing quality, quality systems, regulatory submissions, and inspection readiness. At BD, she led technical quality strategy for complex product platforms and served as an ISO 14971 Risk Management Process Owner, with additional systems-level safety experience including Safety Assurance Case development for infusion systems. Helene’s addition further strengthens GessNet’s ability to help clients address complex product development, quality, manufacturing, and regulatory challenges with deep technical expertise and practical implementation experience. We are excited to have Helene join the team. https://lnkd.in/gUaB7Sep