SUBSCRIBE
Biohealth Innovation
Founding Member of
SUBSCRIBE
Maureen Richard
Entrepreneur in Residence
Maureen Richard is an accomplished medical device software professional with extensive experience in software development lifecycle processes, system engineering, and regulatory compliance for medical device startups. She brings deep expertise in IEC 62304, FDA regulations, and ISO 14971 risk analysis, ensuring software safety and compliance in a highly regulated healthcare environment.
Throughout her career, Maureen has played a pivotal role in developing innovative medical technologies, including point-of-care RT-PCR diagnostic instruments, cloud-based diagnostic platforms, and minimally invasive surgical systems. She has a proven track record in business analysis, workflow design, cybersecurity risk assessment, and project management in Agile environments.
As a consultant, Maureen has successfully guided multiple startups through software development, documentation, and regulatory submission processes. She has developed comprehensive cybersecurity strategies, requirements analysis, software verification plans, and traceability matrices for devices interfacing with clinical networks and cloud-based platforms. Her leadership in software development at Medtronic, Covidien, and GE Healthcare has driven the successful deployment of enterprise-wide medical software solutions.
Maureen holds an MS in Medical Informatics from Northwestern University, a BA in Computer Science from the University of Texas, and a BS in Microbiology from Texas A&M University. She is passionate about advancing medical technology through robust software solutions that enhance patient care and safety.
Located in: Staff