Alba Gutiérrez

Senior Associate

Alba Gutiérrez is a biomedical engineer specialized in Medical Imaging and 3D modelling. She holds a Master in Life Science and a CAS CARAQA in Clinical, Regulatory and Quality Affairs for Medical Devices and In-Vitro Diagnostics. Alba supports with QMS deployment, maintenance and auditing. Her competencies include project management, deployment of MDR compliant technical documentation, including risk management, usability and design verification, and validation activities for software and hardware medical devices. She is experienced in preparing FDA 510(k) submissions and supports you in planning your regulatory strategy. Alba is fluent in English and Spanish and has a good understanding of French.