Marcella Garcia is a seasoned regulatory, quality, and compliance professional with extensive expertise in medical devices, Software as Medical Device (SaMD), and digital health technologies. Currently serving as a Principal Consultant working with multiple early-stage startups globally, she specializes in guiding companies through complex regulatory pathways while building robust quality management systems from the ground up. Marcella earned her Bachelor of Science in Electrical and Computer Engineering from Vanderbilt University (1997-2001) and has continued her professional development with specialized certifications including Healthcare Information Security and Privacy Practitioner (HCISPP) from (ISC)², Certified SAFe Agile Scrum Master, and Cybersecurity for Managers from MIT Professional Education. Her career is distinguished by her ability to thrive in the complex environments that startups inherently present, where rapid change, limited resources, and accelerated timelines are commonplace. She has a particular talent for guiding startups through the critical inflection point of building out their cross-functional teams, leveraging her focus on clear, direct, and honest communication to foster collaboration and drive organizations forward.